Cleared Traditional

K844913 - CORDIS PTA CATHETER-PERCUTANEOUS CATHETER

K844913 is an FDA 510(k) clearance for CORDIS PTA CATHETER-PERCUTANEOUS CATHETER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code LIT cleared through the Traditional 510(k) pathway after a 245-day FDA review.

K844913 · Cordis Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K844913

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.

LIT Device Classification - Class 2, Special Controls

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 264
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K844913.
SCHNEIDER-SHILEY SELDINGER INITIAL PUNCTURE INSTR
K862467 · Shiley, Inc. · Aug 1986
SCHNEIDER-SHILEY PERIPHERAL DILATATION CATHETER
K854319 · Shiley, Inc. · Mar 1986
ADVANCED CARDIOVASCULAR SYSTEMS DOUBLE LUMEN BALLO
K853746 · Advanced Cardiovascular Systems, Inc. · Oct 1985
ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
K851854 · Advanced Cardiovascular Systems, Inc. · Aug 1985
ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
K844972 · Advanced Cardiovascular Systems, Inc. · May 1985
SCIMED PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY DILAT
K850075 · Scimed Life Systems, Inc. · Apr 1985