FDA 510(k)

OPTICAL VALVULOTOME

K-Number: K914385 · 1992-03-02

Decision Date1992-03-02

Product CodeMGZ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OPTICAL VALVULOTOME is the device name listed in this FDA 510(k) record. The listed applicant is Intramed Laboratories, Inc.. It received FDA 510(k) clearance on 1992-03-02 under 510(k) number K914385. 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 OPTICAL VALVULOTOME?

OPTICAL VALVULOTOME is a medical device that received FDA 510(k) clearance on 1992-03-02. The listed applicant is Intramed Laboratories, Inc.. The 510(k) number is K914385.

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

OPTICAL VALVULOTOME received FDA 510(k) clearance on 1992-03-02, under 510(k) number K914385.

Who is the listed applicant for OPTICAL VALVULOTOME?

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

What is the FDA product code for OPTICAL VALVULOTOME?

The FDA product code for OPTICAL 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_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Intramed Laboratories, Inc. as applicant

K953258TITANIUM HEMOSTATIC CLIP K942457GRAFT THROMBECTOMY INSTRUMENTS K931792ARTHROSCOPE K925283VALVULOTOME K934696ANGIOSCOPE K922114ENDOSCOPIC RETRIEVAL BASKET

View all 14 devices →

Related Devices (Code: MGZ)

K260188LimFlow VectorLimFlow, Inc.K250105Boomerang Valvulotome (BMGVT080); Boomerang Push Valvulotome (BMGPVT125)Aveera Medical, Inc.K221902LimFlow VectorLimFlow, Inc.K190267EZE SIT ValvulotomeLemaitre Vascular K132047LEMILLS VALVULOTOMELeMaitre Vascular, Inc.K132190EXPANDABLE LEMAITRE VALVULOTOME, OVER-THE-WIRE LEMAITRE VALVULOTOMELeMaitre Vascular, 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.