Cleared Traditional

K905727 - USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC...

K905727 is the FDA 510(k) clearance for USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC... by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K905727 · C.R. Bard, Inc. · Cardiovascular device
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Feb 1991
Decision
39d
Days
Class 2
Risk

K905727 is an FDA 510(k) clearance for the USCI SATIN FINISH SOFT TIP ANGIOGRAPHIC CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Billerica, US). The FDA issued a Cleared decision on February 1, 1991 after a review of 39 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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 K905727 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 24, 1990
Decision Date February 01, 1991
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 290
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K905727.
ACS ANGIOSCOPIC CATHETER
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MEWISSEN CATHETER
K904788 · Boston Scientific Corp · Dec 1990
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K902771 · Medex, Inc. · Nov 1990