Annuloflex Annuoplasty System, Model Af 800
FDA 510(k) K023185 · Sulzer Carbomedics, Inc.
510(k) numberK023185
Submission
- Device name
- Annuloflex Annuoplasty System, Model Af 800
- Applicant
- Sulzer Carbomedics, Inc.
Austin, TX, US - Received
- September 24, 2002
- Decision date
- December 17, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRH – Ring, Annuloplasty
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3800
- Specialty
- Cardiovascular
- Implant
- Yes
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| K230318 | Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…KRH · Traditional | Corcym S.r.l. | 04/07/2023SE |
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| 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 |
| K974648 | Sulzer Carbomedics Low Profile Mitral RotatorMOP · Traditional | 08/04/1998SE |
| K972201 | Patch,Pledget and Intracardiac,Petp,Ptfe,PolypropyleneDXZ · Traditional | 04/14/1998SE |
Questions and answers
When was Annuloflex Annuoplasty System, Model Af 800 cleared by the FDA?
Annuloflex Annuoplasty System, Model Af 800 (K023185) received a 510(k) decision of Substantially Equivalent on December 17, 2002, 84 days after the submission was received.
What is the product code of K023185?
The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.