THERATEK GROUP EXCHANGE CATHETER
FDA 510(k) clearance K904680 · decided 1990-12-27
Clearance details
- K-number
- K904680
- Device name
- THERATEK GROUP EXCHANGE CATHETER
- Applicant
- Dow Corning Wright
- Decision
- Substantially Equivalent
- Date received
- 1990-10-15
- Decision date
- 1990-12-27
- Days to decision
- 73 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Miami Lakes, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WHITESIDE EPS(TM) FEMORAL HIP PROSTHESIS (P880076/S001) | Dow Corning Wright | 1991-06-17 |