Cleared Traditional

K905548 - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY G...

K905548 is the FDA 510(k) clearance for PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY G... by Mallinckrodt Medical. It is a Class 2 Cardiovascular device (product code DQX) cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K905548 · Mallinckrodt Medical · Cardiovascular device
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Feb 1991
Decision
76d
Days
Class 2
Risk

K905548 is an FDA 510(k) clearance for the PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY GUIDEWIRE. Classified as Wire, Guide, Catheter (product code DQX), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on February 25, 1991 after a review of 76 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 Mallinckrodt Medical devices

Submission Details

510(k) Number K905548 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1990
Decision Date February 25, 1991
Days to Decision 76 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
49d faster than avg
Panel avg: 125d · This submission: 76d
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 520
Devices cleared under the same product code (DQX) and FDA review panel - the closest regulatory comparables to K905548.
OPEN ENDED GUIDEWIRE
K912878 · Lake Region Mfg., Inc. · Sep 1991
.010 HI-TORQUE GUIDE WIRES WITH PRESHAPED TIP
K911460 · Advanced Cardiovascular Systems, Inc. · Jun 1991
CORDIS REFLEX STEERABLE GUIDEWIRE
K905423 · Cordis Corp. · Mar 1991
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K905639 · Lake Region Mfg., Inc. · Feb 1991
SILICONE COATED GUIDEWIRES
K905581 · Lake Region Mfg., Inc. · Feb 1991
.010 HI-TORQUE FLOPPY GUIDE WIRE W/PRESHAPED TIP
K905502 · Advanced Cardiovascular Systems, Inc. · Feb 1991