Cleared Traditional

K905249 - NEW USCI 7F PTCA GUIDING CATHETER

K905249 is the FDA 510(k) clearance for NEW USCI 7F PTCA GUIDING 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 90-day FDA review.

K905249 · C.R. Bard, Inc. · Cardiovascular device
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Feb 1991
Decision
90d
Days
Class 2
Risk

K905249 is an FDA 510(k) clearance for the NEW USCI 7F PTCA GUIDING 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 February 19, 1991 after a review of 90 days - within the typical 510(k) review window.

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 K905249 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1990
Decision Date February 19, 1991
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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 K905249.
SOFTTOUCH(R) GUIDING CATHETER
K912199 · Mallinckrodt Medical · Jul 1991
TURBO SUPPORT CATHETER
K910116 · Datascope Corp. · Jun 1991
CATHCAP, CAT. NO. CC100 SERIES
K911519 · Gish Biomedical, Inc. · May 1991
MULTI-LUMEN CENTRAL VENOUS CATHETER SET
K904404 · Arrow Intl., Inc. · Feb 1991
SOFTOUCH GUIDING CATHETER
K905547 · Mallinckrodt Medical · Feb 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991