510(k) K951368
- Device
- CARBOMEDICS EXENDED MITRAL ROTATOR
- Applicant
- CARBOMEDICS, INC.
- 510(k) number
- K951368
- Product code
- MOP
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1995-06-20
- Date received
- 1995-03-27
- 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
- JOY F SHUGART
- Address
- 1300-A 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 |
| K960923 | CARBOMEDICS MITRAL ROTATOR | Carbomedics, Inc. | 1996-04-29 |
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases