SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
FDA 510(k) clearance K974648 · decided 1998-08-04
Clearance details
- K-number
- K974648
- Device name
- SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR
- Applicant
- Sulzer Carbomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1997-12-12
- Decision date
- 1998-08-04
- Days to decision
- 235 days
- Clearance type
- Traditional
- Product code
- MOP
- Device class
- 1
- Regulation number
- 870.3935
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Austin, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE (K980016) | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-08-07 |
| CARBOMEDICS MITRAL ROTATOR (K960923) | Carbomedics, Inc. | 1996-04-29 |
| CARBOMEDICS EXENDED MITRAL ROTATOR (K951368) | Carbomedics, Inc. | 1995-06-20 |
Recalls involving this device
No recalls on record reference this clearance.