Cleared Traditional

K961232 - 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COATING & 4CM RADIOPAQUE TIP

K961232 is an FDA 510(k) clearance for 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE..., manufactured by Biocompatibles , Ltd.. The device is a Class 2 Cardiovascular device with product code DQX cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K961232 · Biocompatibles , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1996
Decision
89d
Days
Class 2
Risk

K961232 is an FDA 510(k) clearance for the 0.014 FLOPPY & 0.014 INTERMEDIATE GUIDE WIRES W/PHOSPHORYLCHOLINE POLYMER COA.... Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Biocompatibles , Ltd. (Rockville, US). The FDA issued a Cleared decision on June 26, 1996 after a review of 89 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 Biocompatibles , Ltd. devices

FDA 510(k) Submission Details - K961232

510(k) Number K961232 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 1996
Decision Date June 26, 1996
Days to Decision 89 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
36d faster than avg
Panel avg: 125d · This submission: 89d
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 643
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K961232.
ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
K961777 · Cardio Metrics, Inc. · Jul 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
CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS
K960755 · Medtronic Cardiac Surgery, Medtronic, Inc. · May 1996
LRM
K960718 · Lake Region Mfg., Inc. · May 1996
CRICKET
K955304 · Microvena Corp. · May 1996