Sulzer Carbomedics Low Profile Mitral Rotator
FDA 510(k) K974648 · Sulzer Carbomedics, Inc.
510(k) numberK974648
Submission
- Device name
- Sulzer Carbomedics Low Profile Mitral Rotator
- Applicant
- Sulzer Carbomedics, Inc.
Austin, TX, US - Received
- December 12, 1997
- Decision date
- August 4, 1998
- 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 |
| K960923 | Carbomedics Mitral RotatorMOP · Traditional | Carbomedics, Inc. | 04/29/1996SE |
| K951368 | Carbomedics Exended Mitral RotatorMOP · Traditional | Carbomedics, Inc. | 06/20/1995SE |
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|---|---|---|
| K023185 | Annuloflex Annuoplasty System, Model Af 800KRH · Traditional | 12/17/2002SE |
| K013022 | Sulzer Vascutek Gelweave Valsalva Vascular ProsthesisDSY · Traditional | 06/13/2002SE |
| K021051 | Annuloflo System, Mitral Model AR700KRH · Special | 04/23/2002SE |
| K002007 | Sulzer Vascutek Gelsoft Ers Vascular ProsthesisDSY · Traditional | 01/25/2001SE |
| K993288 | Sulzer Carbomedics Cardiofix PericardiumDXZ · Traditional | 12/29/1999SE |
| K992056 | Annuloflex Annuloplasty System, Model AF800KRH · Traditional | 10/12/1999SE |
| K972201 | Patch,Pledget and Intracardiac,Petp,Ptfe,PolypropyleneDXZ · Traditional | 04/14/1998SE |
Questions and answers
When was Sulzer Carbomedics Low Profile Mitral Rotator cleared by the FDA?
Sulzer Carbomedics Low Profile Mitral Rotator (K974648) received a 510(k) decision of Substantially Equivalent on August 4, 1998, 235 days after the submission was received.
What is the product code of K974648?
The FDA product code is MOP – Rotator, Prosthetic Heart Valve, a Class I (low risk) device regulated under 21 CFR 870.3935.