Cleared Traditional

K891069 - USCI CORONARY INFUSION CATHETER

K891069 is an FDA 510(k) clearance for USCI CORONARY INFUSION CATHETER, manufactured by C.R. Bard, Inc.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K891069 · C.R. Bard, Inc. · Cardiovascular device
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Aug 1989
Decision
161d
Days
Class 2
Risk

K891069 is an FDA 510(k) clearance for the USCI CORONARY INFUSION CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on August 9, 1989 after a review of 161 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 C.R. Bard, Inc. devices

FDA 510(k) Submission Details - K891069

510(k) Number K891069 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1989
Decision Date August 09, 1989
Days to Decision 161 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
36d slower than avg
Panel avg: 125d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

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 779
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K891069.
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 1989
USCI PROBING CATHETER
K890152 · C.R. Bard, Inc. · Aug 1989
TARGET CATHETERS AND GUIDE WIRES FOR PEDIATRIC USE
K894084 · Target Therapeutics · Aug 1989
ACS SELECTIVE INFUSION CATHETER
K885237 · Advanced Cardiovascular Systems, Inc. · Mar 1989
ACS SOFT-TIP CORONARY INFUSION CATH W/SIDE HOLES
K883564 · Advanced Cardiovascular Systems, Inc. · Nov 1988
MULTI-MED INFUSION CATHETER AND KIT DOUBLE/TRIPLE
K883174 · Baxter Healthcare Corp · Oct 1988