Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.

K-Number: K800147 · 1980-04-24

ApplicantUsifroid
Decision Date1980-04-24
Product CodeKRH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. is the device name listed in this FDA 510(k) record. The listed applicant is Usifroid. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800147. 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 FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.?

FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Usifroid. The 510(k) number is K800147.

When did FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. receive FDA 510(k) clearance?

FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800147.

Who is the listed applicant for FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.?

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

What is the FDA product code for FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC.?

The FDA product code for FLEXIBLE LINEAR REDUCER F/MITRAL & TRIC. 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

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.

↑