Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The provided text describes a neurovascular access system and its components, focusing on physical characteristics, performance testing, and intended use. There is no mention of AI, ML, or any related computational techniques. The "Mentions AI, DNN, or ML" field explicitly states "Not Found".

Therapeutic

No

Explanation: The device is indicated for the introduction of interventional devices, meaning it facilitates the use of other devices for treatment, rather than directly providing a therapeutic effect itself.

Diagnostic

No

The device is indicated for the introduction of interventional devices, which aligns with therapeutic or access functions rather than diagnostic ones.

SaMD (Software as a Medical Device)

No

The device description explicitly lists physical components like catheters, dilators, sheaths, and access tools, indicating it is a hardware-based medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the "introduction of interventional devices into the peripheral and neurovasculature." This describes a device used in vivo (within the body) for a medical procedure, not a device used in vitro (outside the body) to examine specimens like blood or tissue for diagnostic purposes.
Device Description: The description details catheters, dilators, sheaths, and access tools used for accessing blood vessels. These are all instruments used directly on a patient during a procedure.
Anatomical Site: The device is used in the "peripheral and neurovasculature," which are parts of the circulatory system within the body.
Input Imaging Modality: The device is used under "fluoroscopic imaging conditions," which is a type of real-time X-ray imaging used during medical procedures on a patient.

IVD devices are typically used to analyze samples (blood, urine, tissue, etc.) to diagnose diseases or conditions. This device is clearly designed for a procedural intervention within the body.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Product codes

QJP, DQY

Device Description

The subject SelectFlex Neurovascular Access System Family is a line extension to expand the previously cleared device (K211893) by offering a new SelectFlex III 064 Neurovascular Access Catheter with a diameter of 6F, a 6F dilator, an introducer sheath, and a 4.5F Access Tool that can be used with the catheter to access the desired anatomy. The 4.5F Access Tool is an accessory provided with the SelectFlex III 064 Neurovascular Access Catheter and is packaged in the same sterile pouch with the SelectFlex III 064 Neurovascular Access Catheter and accessories as part of the SelectFlex Neurovascular Access System Family.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

peripheral and neurovasculature

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

Bench testing was performed to evaluate the physical integrity, functionality, and performance of the SelectFlex Neurovascular Access System Family.
Study Type: Bench testing, Biocompatibility testing.
Sample Size: Not specified across all tests, but generally "All samples".
Key Results: All tests passed and met predetermined acceptance criteria. No new safety or performance issues were raised during the testing.
Biocompatibility tests showed:

Cytotoxicity: Non-cytotoxic
Sensitization: Non-sensitizing
Intracutaneous Reactivity: Non-irritant
Acute Systemic Toxicity: Non-toxic
Material Mediated Pyrogenicity: Non-pyrogenic
Hemolysis: Non-hemolytic
Complement Activation: Not a Sc5b-9 complement activator
Thrombogenicity: Non-thrombogenic

Key Metrics

Not Found

Predicate Device(s)

Benchmark Intracranial Access System (K212838)

Reference Device(s)

SelectFlex Neurovascular Access System Family (K211893)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).

Summary

0

June 22, 2023

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Q'Apel Medical, Inc. Kim Ky Manager, Regulatory Affairs 4245 Technology Drive Fremont, California 94538

Re: K230322

Trade/Device Name: SelectFlex Neurovascular Access System Family Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: QJP, DQY Dated: May 23, 2023 Received: May 23, 2023

Dear Kim Ky:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

1

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Naira Muradyan -S

Naira Muradyan, Ph.D. Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

2

Indications for Use

510(k) Number (if known)

K230322

Device Name SelectFlex Neurovascular Access System Family

Indications for Use (Describe)

The SelectFlex Neurovascular Access System Family is introduction of interventional devices into the peripheral and neurovasculature.

Type of Use (Select one or both, as applicable)

X | Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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3

510(k) SUMMARY As required by 21 CFR 807.92

Applicant:

| Submitter's Name:
Address: | Q'Apel Medical Inc.
4245 Technology Drive
Fremont, CA 94538 | Feature | Subject Device
SelectFlex
Neurovascular
Access System
Family | Predicate Device
Benchmark
Intracranial
Access System | Reference Device
SelectFlex
Neurovascular
Access System
Family | Comparison |
|-----------------------------------------|-------------------------------------------------------------------|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------|
| Telephone:
Fax: | 510-738-6255
510-738-6256 | Device Name | SelectFlex
Neurovascular
Access System
Family | Benchmark
Intracranial
Access System | SelectFlex
Neurovascular
Access System
Family | N/A |
| Contact Person:
Title:
Telephone: | Kim Ky
Manager, Regulatory Affairs
510-828-4757 | 510(k) Number | K230322 | K212838 | K211893 | N/A |
| Date Prepared: | June 21, 2023 | Classification | Class II | Class II | Class II | Same |
| Device Trade name: | SelectFlex Neurovascular Access System Family | Product Codes | QJP, DQY | QJP, DQY | QJP, DQY | Same |
| Classification: | Class II | Regulation Number | 870.1250 | 870.1250 | 870.1250 | Same |
| Product Codes: | QJP, DQY | Indications for Use | The SelectFlex
Neurovascular
Access System
Family is indicated
for the introduction
of interventional
devices into the
peripheral and
neurovasculature. | The Benchmark
Intracranial Access
System is indicated
for the introduction
of interventional
devices into the
peripheral, coronary,
and neuro
vasculature. | The SelectFlex
Neurovascular
Access System
Family is indicated
for the introduction
of interventional
devices into the
peripheral and
neurovasculature. | Same |
| Regulation Number: | 21 CFR 870.1250 | Materials | Commonly used
medical-grade
plastics, stainless
steel, nitinol. | Commonly used
medical grade
plastics and stainless
steel. | Commonly used
medical-grade
plastics, stainless
steel, nitinol. | Similar, the
differences do not
raise new
questions
regarding safety
and effectiveness. |
| Classification Name: | Catheter, Percutaneous, Neurovasculature | Outer Diameter (OD) | 6F catheter: 0.083 in | 0.081 – 0.083 in | 7F catheter: 0.095 in | Similar, the
difference does
not raise new
questions
regarding safety
and effectiveness. |
| Predicate Device: | Benchmark Intracranial Access System (K212838) | Inner Diameter (ID) | 6F catheter: 0.064 in Min | 0.070 in Min | 7F catheter: 0.072 in Min | Similar, the
difference does
not raise new
questions
regarding
safety and
effectiveness. |
| Reference Device: | SelectFlex Neurovascular Access System Family (K211893) | Effective length | 95 and 105 cm | 95 and 105 cm | 95, 105, and 115 cm | Same |
| Tip Shape | Straight | Straight & Multi-Purpose | Straight | Same as
reference device | | |
| Injection Port | Yes | Yes | Yes | Same | | |
| Radiopaque | Yes | Yes | Yes | Same | | |

Indications for Use:

The SelectFlex Neurovascular Access System Family is indicated for the introduction of interventional devices into the peripheral and neurovasculature.

Device Description:

The subject SelectFlex Neurovascular Access System Family is a line extension to expand the previously cleared device (K211893) by offering a new SelectFlex III 064 Neurovascular Access Catheter with a diameter of 6F, a 6F dilator, an introducer sheath, and a 4.5F Access Tool that can be used with the catheter to access the desired anatomy. The 4.5F Access Tool is an accessory provided with the SelectFlex III 064 Neurovascular Access Catheter and is packaged in the same sterile pouch with the SelectFlex III 064 Neurovascular Access Catheter and accessories as part of the SelectFlex Neurovascular Access System Family.

4

Comparison of Technological Characteristics with the Predicate and Reference Devices

The subject expanded SelectFlex Neurovascular Access System Family incorporates similar design, packaging, fundamental technology, manufacturing processes, sterilization process, and intended use as the predicate device (K212838) and reference device (K211893).

5

Device Comparison Table
Feature	Subject Device	Predicate Device	Reference Device	Comparison
Device Name	SelectFlex
Neurovascular
Access System
Family	Benchmark
Intracranial
Access System	SelectFlex
Neurovascular
Access System
Family	N/A
Coating length	30 cm	10 cm	11.5 and 30 cm	Same as
reference
device
Shaft
Reinforcement	Stainless steel
reinforced shaft	Stainless steel
reinforced shaft	Stainless steel
reinforced shaft	Same
Variable
Stiffness
Mechanism	Variable
durometer
catheter shaft
construction to
deliver a flexible
distal tip and
transition to a
stiffer proximal
section; ten
transition
segments
between the
distal tip and
proximal shaft.
&
Two user-
selectable variable
stiffness modes of
the distal 10 cm by
application of fluid
into the distal
scaffold chamber
of the catheter
wall. Fluid
pressure enables
the more flexible
tracking mode;
fluid withdrawal
switches to a less
flexible and more
supportive mode.	Variable durometer
catheter shaft
construction.	Variable durometer
catheter shaft
construction to
deliver a flexible
distal tip and
transition to a
stiffer proximal
section; ten
transition
segments between
the distal tip and
proximal shaft.
&
Two user-
selectable
variable stiffness
modes of the
distal 10 cm by
application
of fluid into the
distal scaffold
chamber of the
catheter wall.
Fluid pressure
enables the
more flexible
tracking mode;
fluid withdrawal
switches to a less
flexible and
more supportive
mode.	Same as
reference device
7F Introducer
Sheath	N/A	7F Introducer
Sheath	Same as
reference
device
3 cc syringe	N/A	3 cc syringe	Same as
reference device
Luer Activated
Valve	N/A	Luer Activated
Valve	Same as
reference device
Device Comparison Table
Feature	Subject Device	Predicate Device	Reference Device	Comparison
Device Name	SelectFlex
Neurovascular
Access System
Family
Dilator	Benchmark
Intracranial
Access System	SelectFlex
Neurovascular
Access System
Family
Dilator	N/A
	Effective
Length:
105 and 115 cm
ID: 0.039 ± 0.001
in
OD: 0.060 ±
0.001 in
Tip-Taper
Distance: 0.394
in
Tip-Tapered OD:
0.14 cm

Material:
Hub: CS 00542,
Winged Armadillo
Dilator Hub
Shaft: Pebax 7233
Shaft Colorant:
1.25% Max Foster
MediBatch Slate
Grey
UMBXXX031616C
1 | N/A | Effective Length:
105, 115, 125 cm
ID: 0.039 ± 0.001 in
OD: 0.068 ± 0.001
in
Tip-Taper Distance:
0.591 in
Tip-Tapered OD:
0.14 cm

Material:
Hub: CS 00542,
Winged Armadillo
Dilator Hub
Shaft: Pebax 7233
Shaft Colorant:
1.25% Max Foster
MediBatch Slate
Grey
UMBXXX031616
C1 | Similar to
reference device |
| | 4.5F Access Tool | 5F Select Catheter | N/A | Similar to
predicate device |
| | Effective
Length:
130 and 140
cm
ID: 0.038 in
Min
OD: 4.5F (0.061 in
Max)
Tip Shape:
Simmons

Material:
Commonly used
medical grade
plastics &
stainless steel | Effective Length:
123 and 131.5 cm
ID: 0.043 in Min
OD: 5F (0.069 in
Max)
Tip Shapes:
Berenstein, H1, and
Simmons

Material: Commonly
used medical grade
plastics & stainless
steel | | |
| Guidewire
Compatibility | 0.035 - 0.038 in | 0.035 - 0.038 in | 0.035 - 0.038 in | Same |
| How Supplied | Sterile, single-use | Sterile, single-use | Sterile, single-use | Same |
| Sterilization
method | Ethylene oxide
(EtO) | EtO | EtO | Same |
| Device Comparison Table | | | | |
| Feature | Subject Device | Predicate Device | Reference Device | Comparison |
| Device Name | SelectFlex
Neurovascular
Access System
Family | Benchmark
Intracranial
Access System | SelectFlex
Neurovascular
Access System
Family | N/A |
| Sterility
Assurance
Level | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | Same |
| Shelf-Life | 6 months | 36 months | 36 months | A 6-month
shelf life was
Validated for
the subject
device. |

6

7

8

Nonclinical Performance Data:

The following nonclinical performance testing was conducted to support the determination of substantial equivalence.

Performance Testing Summary:

Bench testing was performed to evaluate the physical integrity, functionality, and performance of the SelectFlex Neurovascular Access System Family:

| Test Name | Goal | Reference
Standard or Guidance | Result |
|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------|
| Visual Surface
Requirements
(SelectFlex III 064
Neurovascular
Access Catheter, 6F
Dilator, 4.5F Access
Tool) | To demonstrate that
the device meets the
visual surface
requirements. | ISO 10555-1 2013:
Intravascular catheters

Sterile and single-
use catheters - Part
1: General requirements | Pass
All samples met the
predetermined
acceptance criteria. |
| Dimensional
Verification
(SelectFlex III 064
Neurovascular
Access Catheter, 6F
Dilator, 4.5F Access
Tool) | To demonstrate that
the device meets the
dimensional
requirements. | ISO 10555-1 2013:
Intravascular catheters
Sterile and single-
use catheters - Part
1: General requirements | Pass
All samples met the
predetermined
acceptance criteria. |
| Liquid Leakage
Under Pressure
(SelectFlex III 064
Neurovascular
Access Catheter) | To demonstrate that
the device passes the
liquid leakage under
pressure test. | ISO 10555-1 2013,
Section 4.7.1, Annex C | Pass
All samples met the
predetermined
acceptance criteria. |
| Hub Aspiration Air
Leakage
(SelectFlex III 064
Neurovascular Access
Catheter) | To demonstrate that
the device passes the
hub aspiration air
leakage test. | ISO 10555-1 2013,
Section 4.7.2, Annex D | Pass
All samples met the
predetermined
acceptance criteria. |
| Simulated
Use/Usability
(SelectFlex III 064
Neurovascular
Access Catheter, 6F
Dilator, 4.5F Access
Tool) | To demonstrate that
the device passes
testing specified in the
simulated use test
protocol.
Simulated use testing
includes usability
assessment with
multiple physicians. | FDA guidance:
"Coronary, Peripheral,
and Neurovascular
Guidewires -
Performance Tests and
Recommended Labeling" | Pass
All samples met the
predetermined
acceptance criteria. |
| Flex Fatigue
(SelectFlex III 064
Neurovascular
Access Catheter, 6F
Dilator, 4.5F Access
Tool) | To demonstrate that
the device passes the
flex fatigue test. | FDA guidance:
"Coronary, Peripheral,
and Neurovascular
Guidewires -
Performance Tests and
Recommended Labeling" | Pass
All samples met the
predetermined
acceptance criteria. |
| Inflation Fatigue | To demonstrate that | ISO 10555-1 2013, | Pass |
| Test Name | Goal | Reference
Standard or Guidance | Result |
| (SelectFlex III 064
Neurovascular Access
Catheter) | the device passes the
inflation fatigue test. | Section 4.7.1 – 20
inflation cycles | All samples met the
predetermined
acceptance criteria. |
| Burst Volume
(SelectFlex III 064
Neurovascular Access
Catheter) | To demonstrate that
the device passes the
burst volume test –
tested to 2x the
inflation volume. | ISO 10555-1 2013:
Intravascular catheters
Sterile and single-
use catheters - Part
1: General requirements | Pass
All samples met the
predetermined
acceptance criteria. |
| Torque Test
(SelectFlex III 064
Neurovascular Access
Catheter, 4.5F Access
Tool) | To demonstrate the
device's ability to
rotate 720 degrees (2
full revolutions) at the
proximal end. | ISO 10555-1 2013:
Intravascular catheters
Sterile and single-
use catheters - Part
1: General requirements | Pass
All samples met the
predetermined
acceptance criteria. |
| Tip Deflection
(SelectFlex III 064
Neurovascular Access
Catheter) | To demonstrate that
the tip deflection is
comparable to the
predicate device. | FDA Guidance:
"Coronary, Peripheral,
and Neurovascular
Guidewires –
Performance Tests and
Recommended Labeling" | Pass
All samples met the
predetermined
acceptance criteria. |
| Device Removal in
Support and Tracking
Modes
(SelectFlex III 064
Neurovascular Access
Catheter) | To demonstrate that
the forces in both
support and tracking
modes are
comparable to the
predicate device. | FDA Guidance:
"Coronary, Peripheral,
and Neurovascular
Guidewires –
Performance Tests and
Recommended Labeling" | Pass
All samples met the
predetermined
acceptance criteria. |
| Peak Tensile
Testing
(SelectFlex III 064
Neurovascular
Access Catheter, 6F
Dilator, 4.5F Access
Tool) | To demonstrate that
the device passes the
peak tensile strength
testing including all
bonds and joints. | ISO 10555-1 2013,
Section 4.6, Annex B | Pass
All samples met the
predetermined
acceptance criteria. |
| Flow Rate
(SelectFlex III 064
Neurovascular Access
Catheter) | To demonstrate that
the flow rate is
comparable to the
predicate device. | ISO 10555-1 2013:
Intravascular catheters
Sterile and single-
use catheters - Part
1: General requirements | Pass
All samples met the
predetermined
acceptance criteria. |
| Corrosion
Resistance
(SelectFlex III 064
Neurovascular
Access Catheter,
4.5F Access Tool) | To demonstrate that
the device has no
visual evidence of
corrosion. | ISO 10555-1 2013,
Section 4.5, Annex A | Pass
All samples met the
predetermined
acceptance criteria. |
| Radiopacity
(SelectFlex III 064
Neurovascular
Access Catheter,
4.5F Access Tool) | To demonstrate that
the marker band is
positioned at the distal
tip of the catheter and
is clearly visible under
typical fluoroscopic
imaging conditions. | ISO 10555-1 2013:
Intravascular catheters
Sterile and single-
use catheters - Part
1: General requirements | Pass
All samples met the
predetermined
acceptance criteria. |
| Test Name | Goal | Reference
Standard or Guidance | Result |
| Particulates, Coating
Integrity, Lubricity,
Durability
(SelectFlex III 064
Neurovascular Access
Catheter) | To demonstrate the
quantity and size of
particles generated
during simulated use
are comparable to the
predicate and
reference devices. | 1. AAMI TIR42:10
Evaluation of
particulates associated
with vascular medical
devices

Intravascular
Catheters, Wires, and
Delivery Systems with
Lubricious Coatings -
Labeling
Considerations, issued
on October 10, 2019. | Pass
All samples met the
predetermined
acceptance criteria. |
| Static Burst
(SelectFlex III 064
Neurovascular
Access Catheter,
4.5F Access Tool) | To demonstrate that
the device passes
static burst as
specified in the test
protocol. | ISO 10555-1 2013:
Intravascular catheters

Sterile and single-
use catheters - Part
1: General requirements | Pass
All samples met the
predetermined
acceptance criteria. |
| Shelf Life
(SelectFlex III 064
Neurovascular
Access Catheter, 6F
Dilator, 4.5F Access
Tool) | To demonstrate that
the device
performance is
maintained over the
proposed shelf-life (6
months). | ASTM D4332,
Standard Practice for
Conditioning Containers,
Packages, or Packaging
Components for
Testing | Pass
All samples met the
predetermined
acceptance criteria. |

9

10

The results of these tests provide reasonable assurance that the subject device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing.

Biocompatibility Testing:

The subject SelectFlex III 064 Neurovascular Access Catheter is categorized as limited exposure (