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)

VALVULOTOME

K-Number: K925283 · 1994-02-10

ApplicantIntramed Laboratories, Inc.
Decision Date1994-02-10
Product CodeMGZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

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 1994-02-10 under 510(k) number K925283. 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 VALVULOTOME?

VALVULOTOME is a medical device that received FDA 510(k) clearance on 1994-02-10. The listed applicant is Intramed Laboratories, Inc.. The 510(k) number is K925283.

When did VALVULOTOME receive FDA 510(k) clearance?

VALVULOTOME received FDA 510(k) clearance on 1994-02-10, under 510(k) number K925283.

Who is the listed applicant for 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 VALVULOTOME?

The FDA product code for 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 Intramed Laboratories, Inc. 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.

K953258TITANIUM HEMOSTATIC CLIPK942457GRAFT THROMBECTOMY INSTRUMENTSK931792ARTHROSCOPEK934696ANGIOSCOPEK922114ENDOSCOPIC RETRIEVAL BASKETK914385OPTICAL VALVULOTOME

View all 14 devices →

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

View on FDA Database →

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

↑