Cleared Traditional

K862724 - VEIN VALVE CUTTER

K862724 is the FDA 510(k) clearance for VEIN VALVE CUTTER by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 169-day FDA review.

K862724 · American Edwards Laboratories · Cardiovascular device
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Jan 1987
Decision
169d
Days
Class 2
Risk

K862724 is an FDA 510(k) clearance for the VEIN VALVE CUTTER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on January 2, 1987 after a review of 169 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 American Edwards Laboratories devices

Submission Details

510(k) Number K862724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1986
Decision Date January 02, 1987
Days to Decision 169 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
44d slower than avg
Panel avg: 125d · This submission: 169d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 577
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K862724.
MEDI-TECH SELECTIVE TORQUE CATHETER
K864118 · Medi-Tech, Inc. · Apr 1987
ADDITIONAL 13.4CM. FRENCH CATHETER INSERTION TRAY
K870675 · Quinton, Inc. · Apr 1987
URESIL SUBCLAVIAN CATHETER
K863684 · Uresil Corp. · Jan 1987
URESIL IRRIGATION CATHETER
K863564 · Uresil Corp. · Oct 1986
TRACKER INFUSION CATHETER
K862117 · Target Therapeutics · Oct 1986
MODIFIED PTCA GUIDING CATHETERS
K862975 · Cordis Corp. · Sep 1986