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Optical Valvulotome

by Intramed Laboratories, Inc.

510(k) K914385

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK914385 Date2 Mar 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MGZ
Device Class
Class II
Regulation
21 CFR Part 870.4885
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Optical Valvulotome is a Class II surgical instrument classified as a valvulotome for cardiovascular use. It is designed to facilitate the removal or incision of venous valves during vascular procedures.

The device is marketed by Intramed Laboratories, Inc. and received FDA 510(k) clearance (K914385) on 1992‑03‑02 under product code MGZ, with a traditional clearance type and a decision of Substantially Equivalent (SESE). It is regulated under 21 CFR 870.4885 and is identified as a Class II device in the cardiovascular specialty.

Other devices from Intramed Laboratories, Inc.

See all devices from Intramed Laboratories, Inc. →

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Optical Valvulotome used for?

    The Optical Valvulotome is a Class II surgical instrument designed to facilitate the removal or incision of venous valves during cardiovascular procedures. It is specifically engineered for use in vascular surgeries where valve modification is required.

  • How is the Optical Valvulotome supplied and is it single-use?

    The device is supplied as a surgical instrument for cardiovascular use. The device data does not specify whether it is single-use or reusable, so clinicians should refer to the manufacturer's instructions for use regarding sterilization and reuse protocols.

  • What regulatory approvals does the Optical Valvulotome have?

    The Optical Valvulotome received FDA 510(k) clearance (K914385) on March 2, 1992, under product code MGZ. It is classified as a Class II device under 21 CFR 870.4885 and is regulated in the cardiovascular specialty with a decision of Substantially Equivalent (SESE).

  • What sizes or models of the Optical Valvulotome are available?

    The device data does not specify different sizes or models of the Optical Valvulotome. Clinicians should consult with Intramed Laboratories, Inc. directly or refer to the product catalog for information regarding available configurations or variations of the instrument.