Cleared Traditional

K851152 - MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR

K851152 is an FDA 510(k) clearance for MC-4000 SURGICAL INSTRUMENTS CARDIOVASCULAR, manufactured by Cryomedics, Inc.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 95-day FDA review.

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

FDA 510(k) Submission Details - K851152

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.

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 54
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K851152.
NAMAN POTTS COURNAND NEEDLE
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MANAN GWI GUIDE WIRE INTRODUCER
K851834 · Manan Manufacturing Co., Inc. · Jul 1985
TELEFLEX MEDICAL INTRODUCER NEEDLE
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GORE-TEX TUNNELER
K844584 · W.L. Gore & Associates, Inc. · Jan 1985
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