GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM
FDA 510(k) clearance K031357 · decided 2004-05-18
Clearance details
- K-number
- K031357
- Device name
- GUARDDOG OCCLUSION SYSTEM, OCCLUSION GUIDEWIRE, 300 CM, GUARDDOG OCCLUSION SYSTEM OCCLUSION GUIDEWIRE, 200 CM
- Applicant
- Possis Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-04-30
- Decision date
- 2004-05-18
- Days to decision
- 384 days
- Clearance type
- Traditional
- Product code
- MJN
- Device class
- 2
- Regulation number
- 870.4450
- 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
No recalls on record reference this clearance.
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 |