Cleared Traditional

K844161 - PTCA GUIDING CATHER

K844161 is an FDA 510(k) clearance for PTCA GUIDING CATHER, manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K844161 · Cordis Corp. · Cardiovascular device
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Jan 1985
Decision
71d
Days
Class 2
Risk

K844161 is an FDA 510(k) clearance for the PTCA GUIDING CATHER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on January 2, 1985 after a review of 71 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 Cordis Corp. devices

FDA 510(k) Submission Details - K844161

510(k) Number K844161 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1984
Decision Date January 02, 1985
Days to Decision 71 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
54d faster than avg
Panel avg: 125d · This submission: 71d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 320
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K844161.
FAP-CATH
K852456 · Research Medical, Inc. · Nov 1985
PATHFINDER CARDIOVASCULAR CATHETER
K844555 · Argon Medical Corp. · Mar 1985
LARIAT CATHETER
K844598 · Mallinckrodt Critical Care · Feb 1985
NAMIC ADB ANGIOGRAPHIC DUMP BAG
K843726 · North American Instrument Corp. · Oct 1984
INTRAOPERATIVE ANGIOSCOPE DELIVERY CATH
K842798 · American Edwards Laboratories · Aug 1984
PERCUTANEOUS ANGIOSCOPE DELIVERY CATH
K842799 · American Edwards Laboratories · Aug 1984