Pounce Thrombus Retrieval System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K192814 FDA 510(k)
- FDA Product Code
- QEW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.5150 FDA 510(k)
- Regulation Number
- 870.5150 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pounce Thrombus Retrieval System is a peripheral mechanical thrombectomy device with aspiration, designed for the non-surgical removal of thrombi and emboli from arterial and venous vasculature. It employs mechanical retrieval techniques to clear occlusions in vessels, including both acute and chronic clots, while optionally accommodating thrombolytic infusion where clinically indicated.
This system is intended for use in a catheter laboratory setting and is supplied as a sterile, single-use device. It is classified as a Class II medical device under FDA regulations (870.5150) and has received 510(k) clearance (K192814). The device is engineered for vessels greater than 6 mm in diameter, with no specific MRI safety considerations noted. Proper storage and handling follow standard sterile medical device protocols.
Frequently asked questions
What types of blood vessels is the Pounce Thrombus Retrieval System designed to treat, and how does it work?
The Pounce Thrombus Retrieval System is specifically designed for use in arterial and venous vasculature with vessels greater than 6 mm in diameter. It employs mechanical retrieval techniques to remove thrombi (blood clots) and emboli (clot fragments) non-surgically, including both acute and chronic clots. The system can also optionally accommodate thrombolytic infusion, which helps dissolve clots chemically while the device mechanically removes debris.
Is the Pounce Thrombus Retrieval System intended for use in specific clinical settings, and how is it supplied?
Yes, the Pounce Thrombus Retrieval System is intended for use in a catheter laboratory setting. It is supplied as a sterile, single-use device, meaning each unit is designed for one-time use only and must be discarded after use to maintain sterility and safety.
How should the Pounce Thrombus Retrieval System be stored, and what are the key considerations for handling?
The Pounce Thrombus Retrieval System should be stored and handled following standard sterile medical device protocols. Since it is a single-use device, it must remain unopened and protected from contamination until ready for use. Proper storage ensures sterility and functionality, adhering to typical guidelines for medical devices in clinical environments.
What regulatory pathway was followed for the approval of the Pounce Thrombus Retrieval System, and what does this mean for its use?
The Pounce Thrombus Retrieval System received FDA clearance through a 510(k) pathway, specifically under the traditional review process with a decision described as 'Substantially Equivalent' to a predicate device. This means the FDA determined that the device is as safe and effective as a legally marketed device that serves as a comparison. Clinically, this clearance indicates the device meets regulatory standards for use in the removal of thrombi and emboli in vessels greater than 6 mm in diameter.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Pounce™ Venous Thrombectomy System, Pounce - Endologix, Pounce Thrombus Retrieval System by Surmodics, Inc. | FDA 510(k) Summary
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K192814 | Class II | Active |
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Manufacturer
- Manufacturer
- Surmodics, Inc.
- FDA Applicant
- Surmodics,Inc.
Sources (1)
- FDA 510(k) K192814 24 fields · synced Sep 20, 2026