XTD THROMBECTOMY CATHETER, XX CM
FDA 510(k) clearance K021641 · decided 2002-07-26
Clearance details
- K-number
- K021641
- Device name
- XTD THROMBECTOMY CATHETER, XX CM
- Applicant
- Xtrak Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-05-20
- Decision date
- 2002-07-26
- Days to decision
- 67 days
- Clearance type
- Special
- Product code
- QEW
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Hopkonton, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system avail recall (Z-2213-2024) | Mermaid Medical A/S | 2024-06-26 |