Cleared Traditional

K961107 - B. BRAUN GUIDEWIRES

K961107 is the FDA 510(k) clearance for B. BRAUN GUIDEWIRES by B.Braun Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K961107 · B.Braun Medical, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Oct 1996
Decision
195d
Days
Class 2
Risk

K961107 is an FDA 510(k) clearance for the B. BRAUN GUIDEWIRES. 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 October 1, 1996 after a review of 195 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

Submission Details

510(k) Number K961107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1996
Decision Date October 01, 1996
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 500
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K961107.
CORDIS ST STEERABLE GUIDEWIRE
K963214 · Cordis Corp. · Nov 1996
CINCH QR SGW EXTENSION
K963171 · Cordis Corp. · Nov 1996
CORDIS STABILIZER PLUS XS
K962932 · Cordis Corp. · Oct 1996
RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL
K961445 · Terumo Medical Corp. · Jul 1996
USCI COMMANDER SERIES GUIDE WIRES
K961271 · C.R. Bard, Inc. · Jun 1996
LRM
K960718 · Lake Region Mfg., Inc. · May 1996