Identity
- Trade Name
- Pounce™ Thrombectomy System FDA UDI
- Generic Name
- Thrombectomy suction catheter FDA UDI
- Device Name
- The Surmodics™ Pounce™ Thrombus Retrieval System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the arterial peripheral vasculature. FDA UDI
- Model / Reference
- PTS-0607-7F135 FDA UDI
- Description
- The Surmodics™ Pounce™ Thrombus Retrieval System is a percutaneous catheter system designed to facilitate mechanical thrombus removal in the arterial peripheral vasculature. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00812339030296 FDA UDI
- 510(k) Number
- K192814 FDA UDI
- FDA Product Code
- QEW FDA UDI
- GMDN Term
- Thrombectomy suction catheter FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 870.5150 FDA UDI
- Commercial Distribution
- Not in Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Dimensions & Sizes
- Size
- Length — 135 Centimeter FDA UDI
Pounce™ Thrombectomy System by Surmodics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Surmodics, Inc.
Sources (1)
- FDA UDI 5af58768-490d-4207-93e0-2b3ab5331f2c 36 fields · synced Jun 6, 2026