(341 days)
Fogarty Arterial Embolectomy Catheters (pre-amendment)
Not Found
No
The description focuses on mechanical action and does not mention any computational or learning components.
Yes
The device is intended for mechanical dissolution of thrombus, which is a therapeutic intervention.
No
The device is used for mechanical dissolution of thrombus (treatment), not for diagnosing a condition.
No
The device description clearly outlines physical components like a catheter, rotor housing, impeller, drive shaft, motor, and infusion line, indicating it is a hardware-based medical device.
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 mechanical dissolution of thrombus within the body (in dialysis fistulae). IVDs are used to examine specimens from the body (like blood, urine, tissue) in vitro (outside the body) to provide information about a person's health.
- Device Description: The device is a catheter designed to be inserted into a blood vessel. This is an invasive procedure performed in vivo.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, using reagents, or performing tests on specimens outside the body.
This device is a therapeutic medical device used for a procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
The Amplatz Thrombectomy Device is intended for mechanical dissolution of acute and subacute thrombus in dialysis fistulae. This device is not intended to be used for the removal of atheroma and is contraindicated in coronary, cerebral, and pulmonary vessels.
Product codes
Not Found
Device Description
The Amplatz Thrombectomy Device is a polyurethane catheter that contains a distal rotor housing in which a small diameter, recessed impeller is attached to a drive shaft. The shaft is connected to a disposable, high-speed air-driven motor. An infusion line with luer connector, attached to the proximal casing, allows infusion of saline, contrast medium, or thrombolytic medications.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
dialysis fistulae
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
clinical studies
Key Metrics
Not Found
Predicate Device(s)
Fogarty Arterial Embolectomy Catheters (pre-amendment)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for Microvena Corporation. The logo features a stylized, double-lined "M" symbol to the left of the word "MICROVENA" in bold, sans-serif font. Below "MICROVENA" is the word "CORPORATION" in a smaller, lighter font, with the letters spaced out.
AUG 13 1996
510(k) SUMMARY
| Contact/Submitter: | Jodi Locher, Manager, Regulatory Affairs |
|---|---|
| Date Prepared: | August 29, 1995 |
| Trade Name: | Amplatz Thrombectomy Device |
| Common Name: | Thrombectomy Catheter |
| Classification Name: | Percutaneous Catheter (per 21 CFR 870.1250) |
| Predicate Devices: | Fogarty Arterial Embolectomy Catheters (pre-amendment) |
| Device Description: | The Amplatz Thrombectomy Device is a polyurethane catheter that contains |
| a distal rotor housing in which a small diameter, recessed impeller is | |
| attached to a drive shaft. The shaft is connected to a disposable, high-speed | |
| air-driven motor. An infusion line with luer connector, attached to the | |
| proximal casing, allows infusion of saline, contrast medium, or thrombolytic | |
| medications. | |
| Intended Use: | The Amplatz Thrombectomy Device is intended for mechanical dissolution |
| of acute and subacute thrombus in dialysis fistulae. This device is not | |
| intended to be used for the removal of atheroma and is contraindicated in | |
| coronary, cerebral, and pulmonary vessels. | |
| Comparative Analysis: | It has been demonstrated (through clinical studies) that the ATD is as safe |
| and effective as surgery for the removal of acute and subacute thrombus | |
| within dialysis fistulae | |
| Functional/Safety | |
| Testing: | The Amplatz Thrombectomy Device has successfully undergone design |
| validation, animal, and clinical testing. | |
| Conclusion: | The Amplatz Thrombectomy Device is substantially equivalent to the |
| predicate device based on the results of laboratory, animal and clinical | |
| testing. |