Simplici-T Annuloplasty System

FDA 510(k) K052970 · Medtronic Heart Valves

Substantially Equivalent

510(k) numberK052970

Submission

Device name
Simplici-T Annuloplasty System
Applicant
Medtronic Heart Valves
Minneapolis, MN, US
Received
October 24, 2005
Decision date
January 11, 2006
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
KRH – Ring, Annuloplasty
Device class
Class II (moderate risk)
Regulation
21 CFR 870.3800
Specialty
Cardiovascular
Implant
Yes

Other 510(k)s with product code KRH

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K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringKRH · Special Corcym S.r.l.06/18/2026SE
K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGKRH · Abbreviated Corcym S.r.l.04/14/2026SE
K253232Seguin Annuloplasty RingKRH · Special Abbott Medical10/29/2025SE
K251982Edwards MC3 Tricuspid annuloplasty ring (4900)KRH · Abbreviated Edwards Lifesciences, LLC09/23/2025SE
K251688Carpentier-Edwards Physio Annuloplasty Ring (4450)KRH · Abbreviated Edwards Lifesciences, LLC09/17/2025SE
K250859TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional Genesee Biomedical, Inc.07/25/2025SE
K232599TransForm McCarthy Mitral Annuloplasty Ring (TF)KRH · Traditional Genesee Biomedical, Inc.04/09/2024SE
K230679WellsForm Tricuspid Annuloplasty Band (WF)KRH · Traditional Genesee Biomedical, Inc.05/26/2023SE
K230318Memo 3D Semirigid Annuloplasty Ring; Memo 3D ReChord Semirigid Annuloplasty Ring; Memo…KRH · Traditional Corcym S.r.l.04/07/2023SE
K202253TruForm Sievers Annuloplasty RingKRH · Traditional Genesee Biomedical, Inc.10/06/2020SE

More from Genesee Biomedical, Inc.

510(k)DeviceDecision
K052860CG Future Annuloplasty BandKRH · Special 11/10/2005SE
K032810Duran Band (Model H607H), Duran Ring (Model 610R), Duran Band (Model 610B), Duran Ancore…KRH · Traditional 12/05/2003SE

Questions and answers

When was Simplici-T Annuloplasty System cleared by the FDA?

Simplici-T Annuloplasty System (K052970) received a 510(k) decision of Substantially Equivalent on January 11, 2006, 79 days after the submission was received.

What is the product code of K052970?

The FDA product code is KRH – Ring, Annuloplasty, a Class II (moderate risk) device regulated under 21 CFR 870.3800.