ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
FDA 510(k) clearance K050794 · decided 2005-04-28
Clearance details
- K-number
- K050794
- Device name
- ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER
- Applicant
- Possis Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-29
- Decision date
- 2005-04-28
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- QEZ
- Device class
- 2
- Regulation number
- 870.5150
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minneapolis, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Possis AngioJet XVG Thrombectomy Sets, Model/Order # 105042-001, Sterilized with Ethylene recall (Z-1131-2007) | Possis Medical, Inc | 2007-08-10 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| POSSIS PERMA-SEAL DIALYSIS ACCESS GRAFT (P980017/S001) | Possis Medical, Inc. | 1999-03-24 |
| PERMA-SEAL DIALYSIS ACCESS GRAFT MODEL 2C20 (P980017) | Possis Medical, Inc. | 1998-09-25 |