FDA product code MOP: Rotator, Prosthetic Heart Valve
MOP is the FDA product code for rotator, prosthetic heart valve. It is a Class I device, regulated under 21 CFR 870.3935 and reviewed by the Cardiovascular panel. FDA has cleared 4 510(k) submissions under MOP, from 3 different applicants. The average 510(k) review took 148 days (median 151).
Classification
| Field | Value |
|---|---|
| Device name | Rotator, Prosthetic Heart Valve |
| Device class | Class I |
| Regulation | 21 CFR 870.3935 |
| Review panel | CV — Cardiovascular |
| Medical specialty | Cardiovascular |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every MOP clearance
Top MOP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Carbomedics, Inc. | 2 | 1996-04-29 |
| Genzyme Surgical Product (Genzyme Biosurgery) | 1 | 1998-08-07 |
| Sulzer Carbomedics, Inc. | 1 | 1998-08-04 |
Most recent MOP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K980016 | Genzyme Surgical Product (Genzyme Biosurgery) | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | 1998-08-07 | 217 |
| K974648 | Sulzer Carbomedics, Inc. | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | 1998-08-04 | 235 |
| K960923 | Carbomedics, Inc. | CARBOMEDICS MITRAL ROTATOR | 1996-04-29 | 54 |
| K951368 | Carbomedics, Inc. | CARBOMEDICS EXENDED MITRAL ROTATOR | 1995-06-20 | 85 |
Recalls for MOP devices
openFDA lists no recalls for product code MOP.
Frequently asked questions
What is FDA product code MOP?
MOP is the FDA product code for rotator, prosthetic heart valve. It is a Class I device, regulated under 21 CFR 870.3935 and reviewed by the Cardiovascular panel.
What device class is MOP?
Class I, regulation 21 CFR 870.3935. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code MOP?
Across 4 cleared submissions the average was 148 days from receipt to decision (median 151).
Which companies have the most MOP clearances?
Carbomedics, Inc. (2); Genzyme Surgical Product (Genzyme Biosurgery) (1); Sulzer Carbomedics, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code MOP
- Run a recall and safety report across every MOP manufacturer
- Watch product code MOP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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