MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
FDA 510(k) clearance K980016 · decided 1998-08-07
Clearance details
- K-number
- K980016
- Device name
- MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE
- Applicant
- Genzyme Surgical Product (Genzyme Biosurgery)
- Decision
- Substantially Equivalent
- Date received
- 1998-01-02
- Decision date
- 1998-08-07
- Days to decision
- 217 days
- Clearance type
- Traditional
- Product code
- MOP
- Device class
- 1
- Regulation number
- 870.3935
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- North Attleboro, MA, 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 |
|---|---|---|
| SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (K974648) | Sulzer Carbomedics, Inc. | 1998-08-04 |
| 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.