Carbomedics Exended Mitral Rotator
FDA 510(k) K951368 · Carbomedics, Inc.
510(k) numberK951368
Submission
- Device name
- Carbomedics Exended Mitral Rotator
- Applicant
- Carbomedics, Inc.
Austin, TX, US - Received
- March 27, 1995
- Decision date
- June 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MOP – Rotator, Prosthetic Heart Valve
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 870.3935
- Specialty
- Cardiovascular
Other 510(k)s with product code MOP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K980016 | Millennium Valve Introducer/Rotator HandleMOP · Traditional | Genzyme Surgical Product (Genzyme Biosurgery) | 08/07/1998SE |
| K974648 | Sulzer Carbomedics Low Profile Mitral RotatorMOP · Traditional | Sulzer Carbomedics, Inc. | 08/04/1998SE |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | Carbomedics, Inc. | 04/29/1996SE |
More from Carbomedics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K970375 | Annuloflo SystemKRH · Traditional | 07/25/1997ST |
| K964665 | Vascutek Gelweave Vascular Graft (Bifurcated Configuration)DSY · Traditional | 02/19/1997ST |
| K962154 | Carbomedics HandleDTJ · Traditional | 08/27/1996SE |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | 04/29/1996SE |
| K960706 | Vascutek Vascusoft Plus Vascular GraftDSY · Traditional | 04/25/1996SESP |
| K960169 | Carbomedics Valve TesterDTJ · Traditional | 04/15/1996SE |
| K955588 | Vascutek Graft Sizer SetDSY · Traditional | 03/07/1996ST |
| K952184 | Carbomedics Supra-Annular Valve SizerDTI · Traditional | 11/29/1995SE |
| K942736 | Carbomedics(R) Prosthetic Heart Valve Holder HandleDTJ · Traditional | 07/06/1994SE |
| K934951 | Valve SizerDTI · Traditional | 12/10/1993SE |
Questions and answers
When was Carbomedics Exended Mitral Rotator cleared by the FDA?
Carbomedics Exended Mitral Rotator (K951368) received a 510(k) decision of Substantially Equivalent on June 20, 1995, 85 days after the submission was received.
What is the product code of K951368?
The FDA product code is MOP – Rotator, Prosthetic Heart Valve, a Class I (low risk) device regulated under 21 CFR 870.3935.