Cleared Traditional

K894682 - USCI UNCOATED GUIDING CATHETERS

K894682 is the FDA 510(k) clearance for USCI UNCOATED GUIDING CATHETERS by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K894682 · C.R. Bard, Inc. · Cardiovascular device
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Sep 1989
Decision
49d
Days
Class 2
Risk

K894682 is an FDA 510(k) clearance for the USCI UNCOATED GUIDING CATHETERS. 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 September 12, 1989 after a review of 49 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 C.R. Bard, Inc. devices

Submission Details

510(k) Number K894682 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1989
Decision Date September 12, 1989
Days to Decision 49 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
76d faster than avg
Panel avg: 125d · This submission: 49d
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 573
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K894682.
CURITY(R) PERCUTANEOUS CATHETERS
K895972 · Kendall Healthcare Products Co. Div.Of Tyco Health · Mar 1990
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · Target Therapeutics · 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
USCI CORONARY INFUSION CATHETER
K891069 · C.R. Bard, Inc. · Aug 1989