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FDA 510(k)

DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H

K-Number: K980534 · 1998-04-30

ApplicantThe Heart Valve Div. Medtronic Cardiovascular Surg
Decision Date1998-04-30
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H is the device name listed in this FDA 510(k) record. The listed applicant is The Heart Valve Div. Medtronic Cardiovascular Surg. It received FDA 510(k) clearance on 1998-04-30 under 510(k) number K980534. 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 DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H?

DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H is a medical device that received FDA 510(k) clearance on 1998-04-30. The listed applicant is The Heart Valve Div. Medtronic Cardiovascular Surg. The 510(k) number is K980534.

When did DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H receive FDA 510(k) clearance?

DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H received FDA 510(k) clearance on 1998-04-30, under 510(k) number K980534.

Who is the listed applicant for DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H?

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

What is the FDA product code for DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H?

The FDA product code for DURAN FLEXIBLE ANNULOPLASTY RING MODEL NUMBER H608H 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 The Heart Valve Div. Medtronic Cardiovascular Surg 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.

K960356POSTERIOR ANNULOPLASTY BAND (MODEL 607)K944956UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, MODEL 6491K922269UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE, 6493K914602DURAN FLEX ANNULOPLASTY RING/OBTUR H601H, MODIFIED

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

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

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