Cleared Traditional

K813514 - EDSLAB CATHETER COVER

K813514 is the FDA 510(k) clearance for EDSLAB CATHETER COVER by American Edwards Laboratories. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K813514 · American Edwards Laboratories · Cardiovascular device
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Dec 1981
Decision
14d
Days
Class 2
Risk

K813514 is an FDA 510(k) clearance for the EDSLAB CATHETER COVER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by American Edwards Laboratories (Walker, US). The FDA issued a Cleared decision on December 29, 1981 after a review of 14 days - a notably fast clearance 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: 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 K813514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1981
Decision Date December 29, 1981
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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 K813514.
MULTIPURPOSE CATHETER
K821189 · Advanced Cardiovascular Systems, Inc. · Jul 1982
ARROW M.I.S. MULTI-LUMEN CATHETERIZA
K820648 · Arrow Intl., Inc. · Apr 1982
ARROW JUGULAR PUNCTURE KIT 16 GA.
K820009 · Arrow Intl., Inc. · Jan 1982
CORDIS DUCOR PTR SYSTEM
K811971 · Cordis Corp. · Aug 1981
ARROW VESSEL CATHETER. KIT W/20GA INDWEL
K810962 · Arrow Intl., Inc. · Apr 1981
BURRON PERCUTANEOUS INDUCER SET
K810460 · Burron Medical Products, Inc. · Mar 1981