Cleared Traditional

K863427 - CLAMPEASE FA

K863427 is an FDA 510(k) clearance for CLAMPEASE FA, manufactured by Freund Medical Products. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K863427 · Freund Medical Products · Cardiovascular device
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Nov 1986
Decision
77d
Days
Class 2
Risk

K863427 is an FDA 510(k) clearance for the CLAMPEASE FA. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Freund Medical Products (Dayton, US). The FDA issued a Cleared decision on November 20, 1986 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Freund Medical Products devices

FDA 510(k) Submission Details - K863427

510(k) Number K863427 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 04, 1986
Decision Date November 20, 1986
Days to Decision 77 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DXC Clamp, Vascular

All 177
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K863427.
PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)
K882879 · Pioneering Technologies, Inc. · Sep 1988
VASCULAR CLAMP
K881158 · T. Korossurgical Instruments Corp. · Jun 1988
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988
MICRO ANASTOMOSIS CLAMP
K861924 · Pilling Co. · Jun 1986
FOGARTY 6MM SOFTJAW CLIP
K832554 · American Edwards Laboratories · Sep 1983
P-S BERLIN VESSEL CLAMP
K820949 · Pudenz-Schulte Medical Research Corp. · Apr 1982