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FDA 510(k)

SIMPLICI-T ANNULOPLASTY SYSTEM

K-Number: K052970 · 2006-01-11

ApplicantMedtronic Heart Valves
Decision Date2006-01-11
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIMPLICI-T ANNULOPLASTY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Heart Valves. It received FDA 510(k) clearance on 2006-01-11 under 510(k) number K052970. The device is classified under product code KRH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIMPLICI-T ANNULOPLASTY SYSTEM?

SIMPLICI-T ANNULOPLASTY SYSTEM is a medical device that received FDA 510(k) clearance on 2006-01-11. The listed applicant is Medtronic Heart Valves. The 510(k) number is K052970.

When did SIMPLICI-T ANNULOPLASTY SYSTEM receive FDA 510(k) clearance?

SIMPLICI-T ANNULOPLASTY SYSTEM received FDA 510(k) clearance on 2006-01-11, under 510(k) number K052970.

Who is the listed applicant for SIMPLICI-T ANNULOPLASTY SYSTEM?

The FDA 510(k) record lists Medtronic Heart Valves as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIMPLICI-T ANNULOPLASTY SYSTEM?

The FDA product code for SIMPLICI-T ANNULOPLASTY SYSTEM is KRH.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Medtronic Heart Valves as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K052860CG FUTURE ANNULOPLASTY BANDK032810DURAN BAND (MODEL H607H), DURAN RING (MODEL 610R), DURAN BAND (MODEL 610B), DURAN ANCORE RING (MODEL 620R), DURAN ANCORE

Related Devices (Code: KRH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261707MEMO 4D Curve™ Semirigid mitral annuloplasty ringCorcym S.r.l.K260498TriMemo™ SEMIRIGID ANNULOPLASTY RINGCorcym S.r.l.K253232Seguin Annuloplasty RingABBOTT MEDICALK251982Edwards MC3 Tricuspid annuloplasty ring (4900)Edwards Lifesciences, LLCK251688Carpentier-Edwards Physio Annuloplasty Ring (4450)Edwards Lifesciences, LLCK250859TransForm McCarthy Mitral Annuloplasty Ring (TF)Genesee Biomedical, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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