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FDA 510(k)

ANNULUS VALVULOTOME

K-Number: K912636 · 1991-10-18

ApplicantCardio Source
Decision Date1991-10-18
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANNULUS VALVULOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Source. It received FDA 510(k) clearance on 1991-10-18 under 510(k) number K912636. The device is classified under product code MGZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANNULUS VALVULOTOME?

ANNULUS VALVULOTOME is a medical device that received FDA 510(k) clearance on 1991-10-18. The listed applicant is Cardio Source. The 510(k) number is K912636.

When did ANNULUS VALVULOTOME receive FDA 510(k) clearance?

ANNULUS VALVULOTOME received FDA 510(k) clearance on 1991-10-18, under 510(k) number K912636.

Who is the listed applicant for ANNULUS VALVULOTOME?

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

What is the FDA product code for ANNULUS VALVULOTOME?

The FDA product code for ANNULUS VALVULOTOME is MGZ.

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 Cardio Source 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.

K912635ANNULUS DISPOSABLE VALVULOTOME

Related Devices (Code: MGZ)

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.

K260188LimFlow VectorLimFlow, Inc.K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.K221902LimFlow VectorLimFlow, Inc.K190267EZE SIT ValvulotomeLemaitre VascularK132047LEMILLS VALVULOTOMELeMaitre Vascular, Inc.K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, 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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