Cleared Traditional

K850394 - LEMAITRE RETROGRADE VALVULOTOME-MANU-SU...

K850394 is an FDA 510(k) clearance for LEMAITRE RETROGRADE VALVULOTOME-MANU-SU..., manufactured by Vascutech, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K850394 · Vascutech, Inc. · Cardiovascular device
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Apr 1985
Decision
82d
Days
Class 1
Risk

K850394 is an FDA 510(k) clearance for the LEMAITRE RETROGRADE VALVULOTOME-MANU-SURGICA INSTR. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Vascutech, Inc. (Washington, US). The FDA issued a Cleared decision on April 24, 1985 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Vascutech, Inc. devices

FDA 510(k) Submission Details - K850394

510(k) Number K850394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 1985
Decision Date April 24, 1985
Days to Decision 82 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 125d · This submission: 82d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 40
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K850394.
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