Cleared Traditional

K850353 - CORONARY INFUSION CATHETER W/SIDEHOLES

K850353 is the FDA 510(k) clearance for CORONARY INFUSION CATHETER W/SIDEHOLES by Advanced Cardiovascular Systems, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 71-day FDA review.

K850353 · Advanced Cardiovascular Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1985
Decision
71d
Days
Class 2
Risk

K850353 is an FDA 510(k) clearance for the CORONARY INFUSION CATHETER W/SIDEHOLES. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Advanced Cardiovascular Systems, Inc. (Mountain View, US). The FDA issued a Cleared decision on April 10, 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 870.1250 - 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 Advanced Cardiovascular Systems, Inc. devices

Submission Details

510(k) Number K850353 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 29, 1985
Decision Date April 10, 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.

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 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K850353.
MAHURKAR SUBCLAVIAN CATHETER INSERTION KIT
K852388 · Quinton, Inc. · Aug 1985
BARD-PARKER IRRIGATION CATHETER
K852099 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1985
WIRE, GUIDE, CATHETER
K850829 · Lake Region Mfg., Inc. · Jun 1985
ARROW-JOHANS ECG ADAPTOR
K843263 · Arrow Intl., Inc. · Sep 1984
CARDIAC SUPPLY TRAY
K842645 · Deroyal Industries, Inc. · Aug 1984
MULTIPRO CATHETER
K841797 · Shiley, Inc. · Aug 1984