Cleared Traditional

K864461 - MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE...

K864461 is the FDA 510(k) clearance for MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE... by Medsurg Industries, Inc.. It is a Class 1 Cardiovascular device (product code DWS) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K864461 · Medsurg Industries, Inc. · Cardiovascular device
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Nov 1986
Decision
12d
Days
Class 1
Risk

K864461 is an FDA 510(k) clearance for the MEDSURG CUSTOM CARDIOVASCULAR PROCEDURE TRAY. Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Medsurg Industries, Inc. (Herndon, US). The FDA issued a Cleared decision on November 24, 1986 after a review of 12 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 Medsurg Industries, Inc. devices

Submission Details

510(k) Number K864461 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1986
Decision Date November 24, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 125d · This submission: 12d
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.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 18
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K864461.
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K802079 · Howmedica Corp. · Sep 1980