Cleared Traditional

MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR (K851152) - FDA 510(k) Clearance

Class I Cardiovascular device.

K851152 · Cryomedics, Inc. · Cardiovascular device
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Jun 1985
Decision
95d
Days
Class 1
Risk

K851152 is an FDA 510(k) clearance for the MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Cryomedics, Inc. (Bridgeport, US). The FDA issued a Cleared decision on June 24, 1985 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Cryomedics, Inc. devices

Submission Details

510(k) Number K851152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1985
Decision Date June 24, 1985
Days to Decision 95 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 125d · This submission: 95d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.