Cleared Traditional

K960056 - USCI PRO FLO XT

K960056 is the FDA 510(k) clearance for USCI PRO FLO XT by C.R. Bard, Inc.. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Traditional 510(k) pathway after a 293-day FDA review.

K960056 · C.R. Bard, Inc. · Cardiovascular device
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Oct 1996
Decision
293d
Days
Class 2
Risk

K960056 is an FDA 510(k) clearance for the USCI PRO FLO XT,SOFT TIP, AND XT SOFT TIP ANGIOGRAPHIC. 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 October 23, 1996 after a review of 293 days - an extended review 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: 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 K960056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1996
Decision Date October 23, 1996
Days to Decision 293 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
168d slower than avg
Panel avg: 125d · This submission: 293d
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 K960056.
3F ANGIOPTIC ANGIOGRAPHIC CATHETER
K964033 · AngioDynamics, Inc. · May 1997
SPYGLASS ANGIOGRAPHIC CATHETER
K965249 · Daig Corp. · Feb 1997
SCIMED 5 FRENCH IMPULSE ANGIOGRAPHIC CATHETERS
K964859 · Scimed Life Systems, Inc. · Feb 1997
LAGUNA SOFTIP DIAGNOSTIC CATHETERS
K961499 · Boston Scientific Scimed, Inc. · Oct 1996
SPYGLASS ANGIOGRAPHIC CATHETER
K962805 · Daig Corp. · Oct 1996
4F NYLEX ANGIOGRAPHIC CATHETER
K962759 · Cordis Corp. · Oct 1996