Cleared Traditional

CORDIS PTA CATHETER-PERCUTANEOUS CATHETER (K844913) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K844913 · Cordis Corp. · Cardiovascular device
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Aug 1985
Decision
245d
Days
Class 2
Risk

K844913 is an FDA 510(k) clearance for the CORDIS PTA CATHETER-PERCUTANEOUS CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on August 20, 1985 after a review of 245 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 Cordis Corp. devices

Submission Details

510(k) Number K844913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1984
Decision Date August 20, 1985
Days to Decision 245 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
120d slower than avg
Panel avg: 125d · This submission: 245d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 167
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K844913.
DOTTER BALLOON TRANSLUMINAL ANGIO. CATHETER (POLY)
K870215 · Cook, Inc. · Aug 1987
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · Shiley, Inc. · Aug 1986
SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER
K854319 · Shiley, Inc. · Mar 1986
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT
K850075 · Scimed Life Systems, Inc. · Apr 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY CATHETER
K850760 · Scimed Life Systems, Inc. · Apr 1985
MILLS OPERATIVE PERIPHERAL ANGIOPLASTY
K841961 · Scimed Life Systems, Inc. · Oct 1984