Cleared Traditional

K890152 - USCI PROBING CATHETER

K890152 is the FDA 510(k) clearance for USCI PROBING CATHETER by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K890152 · C.R. Bard, Inc. · Cardiovascular device
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Aug 1989
Decision
216d
Days
Class 2
Risk

K890152 is an FDA 510(k) clearance for the USCI PROBING 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 17, 1989 after a review of 216 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

Submission Details

510(k) Number K890152 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1989
Decision Date August 17, 1989
Days to Decision 216 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
91d slower than avg
Panel avg: 125d · This submission: 216d
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 K890152.
QUINTON MAHURKAR CATHETERS W/VITACUFF
K895440 · Quinton, Inc. · Nov 1989
TARGET THERAPEUTICS TRACKER LF CATHETER
K894105 · Target Therapeutics · Sep 1989
USCI UNCOATED GUIDING CATHETERS
K894682 · C.R. Bard, Inc. · Sep 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
ACS SELECTIVE INFUSION CATHETER
K885237 · Advanced Cardiovascular Systems, Inc. · Mar 1989