Cleared Traditional

DISPOSABLE OPTICAL VALVULOTOME

K914457 · Nobles-Lai Engineering, Inc. · Cardiovascular
Feb 1992
Decision
121d
Days
Class 2
Risk

About This 510(k) Submission

K914457 is an FDA 510(k) clearance for the DISPOSABLE OPTICAL VALVULOTOME, a Valvulotome (Class II — Special Controls, product code MGZ), submitted by Nobles-Lai Engineering, Inc. (Costa Mesa, US). The FDA issued a Cleared decision on February 5, 1992, 121 days after receiving the submission on October 7, 1991. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4885.

Submission Details

510(k) Number K914457 FDA.gov
FDA Decision Cleared SESE
Date Received October 07, 1991
Decision Date February 05, 1992
Days to Decision 121 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code MGZ — Valvulotome
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4885

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