Cleared Traditional

K832554 - FOGARTY 6MM SOFTJAW CLIP

K832554 is the FDA 510(k) clearance for FOGARTY 6MM SOFTJAW CLIP by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K832554 · American Edwards Laboratories · Cardiovascular device
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Sep 1983
Decision
59d
Days
Class 2
Risk

K832554 is an FDA 510(k) clearance for the FOGARTY 6MM SOFTJAW CLIP. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by American Edwards Laboratories (Mchenry, US). The FDA issued a Cleared decision on September 29, 1983 after a review of 59 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 American Edwards Laboratories devices

Submission Details

510(k) Number K832554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 01, 1983
Decision Date September 29, 1983
Days to Decision 59 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 61
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K832554.
RMI VASCULAR TOURNIQUET KIT
K910221 · Research Medical, Inc. · May 1991
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988
MICRO ANASTOMOSIS CLAMP
K861924 · Pilling Co. · Jun 1986
P-S BERLIN VESSEL CLAMP
K820949 · Pudenz-Schulte Medical Research Corp. · Apr 1982
FOGARTY SOFTJAW 6MM SPRING CLIP, #614-06
K810162 · American Edwards Laboratories · Feb 1981
VESSEL RETRACTOR, #600732
K802244 · Bentley Laboratories, Inc. · Oct 1980