FDA Product Code
FDA Product Code MOP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3935
510(k) Clearances — 4 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-08-07 | Traditional | PDF ↗ |
| K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | Sulzer Carbomedics, Inc. | 1998-08-04 | Traditional | PDF ↗ |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Carbomedics, Inc. | 1996-04-29 | Traditional | PDF ↗ |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Carbomedics, Inc. | 1995-06-20 | Traditional | PDF ↗ |
Product code MOP · Class I · Cardiovascular. Data: openFDA.