Cleared Traditional

K843141 - CRITIKON HEPARIN-COATED CARDIOVASCULAR

K843141 is an FDA 510(k) clearance for CRITIKON HEPARIN-COATED CARDIOVASCULAR, manufactured by Critikon Company, LLC. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K843141 · Critikon Company, LLC · Cardiovascular device
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Sep 1984
Decision
26d
Days
Class 2
Risk

K843141 is an FDA 510(k) clearance for the CRITIKON HEPARIN-COATED CARDIOVASCULAR. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Critikon Company, LLC (Walker, US). The FDA issued a Cleared decision on September 4, 1984 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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 Critikon Company, LLC devices

FDA 510(k) Submission Details - K843141

510(k) Number K843141 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1984
Decision Date September 04, 1984
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
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 - LDF Electrode, Pacemaker, Temporary

All 82
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K843141.
ELECATH OPEN TIP BIPOLAR PACING CATHETER
K850324 · Electro-Catheter Corp. · Mar 1985
NUMED BALLOON PACING CATHETER
K843290 · NuMED, Inc. · Jan 1985
ELECATH VENTRICULAR PACING WEDGE PRESSURE CATH
K844003 · Electro-Catheter Corp. · Dec 1984
LUMELEC ELECTRODE CATHETER
K834416 · Cordis Corp. · Apr 1984
ELECATH HEPARIN COATED TEMP. PACING
K840109 · Electro-Catheter Corp. · Feb 1984
TEMP. CARDIAC PACING WIRE TME 60/61/65
K831695 · Oscor, Inc. · Oct 1983