MITRAL VALVE ORIFICE SIZER
FDA 510(k) clearance K820887 · decided 1982-07-08
Clearance details
- K-number
- K820887
- Device name
- MITRAL VALVE ORIFICE SIZER
- Applicant
- Celtech
- Decision
- Substantially Equivalent
- Date received
- 1982-03-30
- Decision date
- 1982-07-08
- Days to decision
- 100 days
- Clearance type
- Traditional
- Product code
- DTI
- Device class
- 1
- Regulation number
- 870.3945
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Celtech
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 |
|---|---|---|
| CARBOMEDICS SUPRA-ANNULAR VALVE SIZER (K952184) | Carbomedics, Inc. | 1995-11-29 |
| VALVE SIZER (K934951) | Carbomedics, Inc. | 1993-12-10 |
| EDWARDS-DUROMEDICS BILEAFLET VALVE SIZER SET (K881279) | Baxter Healthcare Corp | 1988-05-18 |
| DUROMEDICS CARDIAC VALVE SIZER SET (K853313) | Hemex Scientific, Inc. | 1985-11-01 |
| METRONIC MODEL F7700 HEART VALVE SIZERS (K852612) | Medtronic Vascular | 1985-09-23 |
| HANCOCK * OBTURATORS (K801885) | Hancock Laboratories, Inc. | 1980-09-09 |
Recalls involving this device
No recalls on record reference this clearance.