Cleared Traditional

K964352 - TORQUE DEVICE

K964352 is the FDA 510(k) clearance for TORQUE DEVICE by B.Braun Medical, Inc.. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K964352 · B.Braun Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
88d
Days
Class 2
Risk

K964352 is an FDA 510(k) clearance for the TORQUE DEVICE. 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 January 28, 1997 after a review of 88 days - a notably fast clearance 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: 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 B.Braun Medical, Inc. devices

Submission Details

510(k) Number K964352 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 1996
Decision Date January 28, 1997
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
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 K964352.
SCIMED CHOICE FAMILY OF PTCA GUIDE WIRES
K970244 · Scimed Life Systems, Inc. · Mar 1997
CHOICE PT PLUS PTCA GUIDE WIRE AND CHOICE PT VISION PTCA GUIDE WIRE
K965023 · Scimed Life Systems, Inc. · Mar 1997
CORDIS MARKER WIRE STEERABLE GUIDEWIRE (STABILIZER WITH RADIOPAQUE MARKERS) AND (WIZDOM WITH RADIOPAQUE MARKERS)
K962765 · Cordis Corp. · Feb 1997
TRANSEND GUIDEWIRE
K964611 · Boston Scientific Corp · Jan 1997
ACS HI-TORQUE IRON MAN GUIDE WIRE
K963702 · Advanced Cardiovascular Systems, Inc. · Jan 1997
SCIMED CHOICE PT VISION PTCA GUIDE WIRE
K962572 · Scimed Life Systems, Inc. · Dec 1996