510(k) K960923
- Device
- CARBOMEDICS MITRAL ROTATOR
- Applicant
- CARBOMEDICS, INC.
- 510(k) number
- K960923
- Product code
- MOP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-04-29
- Date received
- 1996-03-06
- Regulation
- 870.3935
- Classification name
- Rotator, Prosthetic Heart Valve
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAVID M MAKANANI
- Address
- 1300-C E. Anderson Ln. Austin TX US 78752 78752
Source Documents#
Other 510(k) Records For Product Code MOP #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K980016 | MILLENNIUM VALVE INTRODUCER/ROTATOR HANDLE | Genzyme Surgical Product (Genzyme Biosurgery) | 1998-08-07 |
| K974648 | SULZER CARBOMEDICS LOW PROFILE MITRAL ROTATOR | Sulzer Carbomedics, Inc. | 1998-08-04 |
| K951368 | CARBOMEDICS EXENDED MITRAL ROTATOR | Carbomedics, Inc. | 1995-06-20 |
Legacy Summary#
summary
FDA Review#
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