CARBOMEDICS EXENDED MITRAL ROTATOR
FDA 510(k) clearance K951368 · decided 1995-06-20
Clearance details
- K-number
- K951368
- Device name
- CARBOMEDICS EXENDED MITRAL ROTATOR
- Applicant
- Carbomedics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-03-27
- Decision date
- 1995-06-20
- Days to decision
- 85 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
+ Add to Predicate Builder ◉ Watch Carbomedics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR (K974648) | Sulzer Carbomedics, Inc. | 1998-08-04 |
| CARBOMEDICS MITRAL ROTATOR (K960923) | Carbomedics, Inc. | 1996-04-29 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S001) | Carbomedics, Inc. | 1995-07-05 |
| VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S005) | Carbomedics, Inc. | 1995-04-13 |
| VASCUTEK GELSEAL(TM) VASCULAR GRAFT (P890045/S006) | Carbomedics, Inc. | 1994-07-22 |
| VASCUTEK GELSOFT(TM) VASCULAR GRAFT (P890045/S003) | Carbomedics, Inc. | 1993-12-07 |
| GELSEAL TM TRIAXIAL VASCULAR GRAFT (P890045) | Carbomedics, Inc. | 1993-01-11 |