Product Code: MOP
FDA class 1
21 CFR 870.3935
Rotator, Prosthetic Heart Valve
Cardiovascular
The Prosthetic Heart Valve Rotator is a cardiovascular surgical instrument used to orient and position a prosthetic heart valve during implantation surgery, ensuring correct placement and alignment. Classified as FDA Class 1 under 21 CFR 870.3935, it is 510(k)-exempt and subject only to general controls. The product code is MOP, reviewed by the Cardiovascular panel.
510(k)s
4
FEI Numbers
0
Registration Numbers
0
Unique Applicants
3
Years Active
3
Research product code MOP in seconds
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Basic Information
- Product Code
- MOP
- Device Class
- FDA class 1
- Regulation Number
- 870.3935
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | Aug 07, 1998 | Substantially Equivalent | Genzyme Surgical Product (Genzyme Biosurgery) |
| K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | Aug 04, 1998 | Substantially Equivalent | Sulzer Carbomedics, Inc. |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Apr 29, 1996 | Substantially Equivalent | Carbomedics, Inc. |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Jun 20, 1995 | Substantially Equivalent | Carbomedics, Inc. |