Cleared Traditional

K961445 - RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL

K961445 is an FDA 510(k) clearance for RADIFOCUS GLIDEWIRE FOR CORONARY USE WI..., manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K961445 · Terumo Medical Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jul 1996
Decision
84d
Days
Class 2
Risk

K961445 is an FDA 510(k) clearance for the RADIFOCUS GLIDEWIRE FOR CORONARY USE WITH PLATINUM (OR GOLD) COIL. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on July 9, 1996 after a review of 84 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 Terumo Medical Corp. devices

FDA 510(k) Submission Details - K961445

510(k) Number K961445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1996
Decision Date July 09, 1996
Days to Decision 84 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
41d faster than avg
Panel avg: 125d · This submission: 84d
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 718
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K961445.
B. BRAUN GUIDEWIRES
K961107 · B.Braun Medical, Inc. · Oct 1996
0.014 INCH EXTRA LONG FLOPPY AND 0.014 EXTRA LONG INTERMEDIATE GUIDE WIRES WITH PHOSPHORYLCHOLINE (PC) POLYMER COATING
K962266 · Biocompatibles Cardiovascular, Inc. · Sep 1996
ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
K961777 · Cardio Metrics, Inc. · Jul 1996
USCI COMMANDER SERIES GUIDE WIRES
K961271 · C.R. Bard, Inc. · Jun 1996
0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP
K961232 · Biocompatibles , Ltd. · Jun 1996
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
K960755 · Medtronic Cardiac Surgery, Medtronic, Inc. · May 1996