Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

Device Description

The Telescope™ Guide Extension Catheter is a single-lumen rapid exchange catheter designed to act as an extension to a traditional guide catheter. The Telescope™ Guide Extension Catheter is intended to be used with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

The Telescope™ Guide Extension Catheter device is 150cm in length and consists of a hydrophilic-coated single-lumen distal guide segment connected to a stainless-steel polytetrafluoroethylene (PTFE) coated proximal pushwire.

The device is offered in two sizes 6F and 7F, with a hub at the proximal end of the pushwire that is used for device identification.

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - Telescope Guide Extension Catheter

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U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

October 29, 2025

Medtronic Ireland
Denise Keehan
Principal Regulatory Affairs Specialist
Parkmore Business Park West
Galway, H91 VY19
Ireland

Re: K252390
Trade/Device Name: Telescope Guide Extension Catheter
Regulation Number: 21 CFR 870.1250
Regulation Name: Percutaneous Catheter
Regulatory Class: Class II
Product Code: DQY
Dated: July 25, 2025
Received: July 31, 2025

Dear Denise Keehan:

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 (the 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 available 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.

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K252390 - Denise Keehan
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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

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K252390 - Denise Keehan
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assistance/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,

Jenny R. Katsnelson -S
Digitally signed by Jenny R. Katsnelson -S
Date: 2025.10.29 18:09:08 -04'00'

for Lydia Glaw
Assistant Director
DHT2C: Division of Coronary and Peripheral Intervention Devices
OHT2: Office of Cardiovascular Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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FORM FDA 3881 (6/20)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known): K252390

Device Name: Telescope Guide Extension Catheter

Indications for Use (Describe):
Telescope™ Guide Extension Catheter is intended to be used in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, and to facilitate placement of interventional devices.

Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Traditional 510(k) Summary per 21 CFR 807.92

Date Prepared: July 31, 2025

Submitter: Medtronic Ireland
Parkmore Business Park West
Galway
Ireland
H91 VY19

Applicant Contact: Denise Keehan
Principal Regulatory Affairs Specialist
Phone: (011-353) 87 4658517
Email: denise.keehan@medtronic.com

Alternate Contact: Laura Guinane
Senior Regulatory Affairs Program Manager
Phone: (011-353) 86 1051563
Email: laura.m.guinane@medtronic.com

Trade Name: Telescope™ Guide Extension Catheter

Common Name: Percutaneous Catheter

Device Classification: Class II

Classification Name: Catheter, Percutaneous

Classification Panel: Cardiovascular

Regulation Number: 21 CFR 870.1250

Product Code: DQY (Percutaneous Catheter)

Predicate Device Name: Telescope™ Guide Extension Catheter
K183353, Clearance Date: March 22, 2019

K252390
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K252390
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Device Description

The device is offered in two sizes 6F and 7F, with a hub at the proximal end of the pushwire that is used for device identification.

Intended Use/Indications for Use

Comparison to Predicate Device

The overall design and technological features are the same as the predicate, which is Medtronic's own legally marketed device. This includes product sizes, dimensions, and configuration. There is no change in the sterilization method, sterility assurance level or shelf life. The main technological difference is a material change to the predicate.

Summary of Non-Clinical Data

The following non-clinical testing was performed to evaluate and demonstrate substantial equivalence between the predicate and subject device.

Performance testing

Pushwire Outer Diameter
Exit Marker Position: Distal and Proximal
Deliverability
Simulated Use
Coating Integrity
Particulates

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K252390
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Biocompatibility Evaluation (conducted per ISO 10993 Standards)

Cytotoxicity
Sensitization
Irritation
Acute Systemic Toxicity Testing
Material Mediated Pyrogenicity Testing
Hemocompatibility
- Hemolysis
- Complement Activation
- Partial Thromboplastin Time (PTT)
- Platelet/Leucocyte Count

All test results met the acceptance criteria, which are consistent with the predicate device, demonstrating that the subject device meets established design inputs and is suitable for its intended use.

Summary of Clinical Data

No clinical testing was required for this 510(k) submission.

Conclusion from Data:

The difference between the subject and predicate devices has been evaluated through non-clinical testing, which demonstrates that the subject device is substantially equivalent to the predicate device.

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).