Cleared Traditional

K971086 - RADIAL AND FEMORAL ARTERY CATHETER

K971086 is an FDA 510(k) clearance for RADIAL AND FEMORAL ARTERY CATHETER, manufactured by B.Braun Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K971086 · B.Braun Medical, Inc. · Cardiovascular device
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Dec 1997
Decision
269d
Days
Class 2
Risk

K971086 is an FDA 510(k) clearance for the RADIAL AND FEMORAL ARTERY CATHETER. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on December 19, 1997 after a review of 269 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1330 - 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 B.Braun Medical, Inc. devices

FDA 510(k) Submission Details - K971086

510(k) Number K971086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 1997
Decision Date December 19, 1997
Days to Decision 269 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
144d slower than avg
Panel avg: 125d · This submission: 269d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQX Device Classification - Class 2, Special Controls

Product Code DQX Wire, Guide, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1330
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 - DQX Wire, Guide, Catheter

All 681
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K971086.
HI-TORQUE FLOPPY GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE STANDARD GUIDE WIRE WITH HYDROCOAT HYDROPHILIC
K974773 · Guidant Corp. · Mar 1998
LUGE GUIDE WIRE
K973945 · Scimed Life Systems, Inc. · Jan 1998
CORDIS HYDRONOL STEERABLE GUIDEWIRE
K973845 · Cordis Corp. · Jan 1998
TOMCAT GUIDE WIRE, EXTENDER WIRE, GUIDE WIRE EXTENSION TOOL
K973708 · Merit Medical Systems, Inc. · Dec 1997
HI-TORQUE BALANCE GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE WITH HYDG
K973494 · Guidant Corp. · Dec 1997
IVT 0.014 PTFE-COATED TRACKWIRE
K971688 · Boston Scientific /International Technologies · Dec 1997