SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
FDA 510(k) clearance K993667 · decided 2000-01-28
Clearance details
- K-number
- K993667
- Device name
- SULZER VASCUTEK SEALPTFE VASCULAR PROSTHESIS
- Applicant
- Sulzermedica
- Decision
- Substantially Equivalent
- Date received
- 1999-11-01
- Decision date
- 2000-01-28
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- DSY
- Device class
- 2
- Regulation number
- 870.3450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, 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 |
|---|---|---|
| NATURAL-KNEE AND NATURAL-KNEE II (P940002/S005) | Sulzermedica | 2001-08-01 |
| NATURAL KNEE & NATURAL KNEE II (P940002/S003) | Sulzermedica | 2000-04-18 |
| NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S002) | Sulzermedica | 1997-10-16 |
| NATURAL-KNEE(R) WITH CSTI(TM) (P940002/S001) | Sulzermedica | 1997-04-30 |
| NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM) (P940002) | Sulzermedica | 1997-03-21 |