Cleared Traditional

K905773 - PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY C...

K905773 is the FDA 510(k) clearance for PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY C... by Mallinckrodt Medical. It is a Class 2 Cardiovascular device (product code LIT) cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K905773 · Mallinckrodt Medical · Cardiovascular device
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Jan 1991
Decision
34d
Days
Class 2
Risk

K905773 is an FDA 510(k) clearance for the PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY CATHETER. Classified as Catheter, Angioplasty, Peripheral, Transluminal (product code LIT), Class II - Special Controls.

Submitted by Mallinckrodt Medical (St Louis, US). The FDA issued a Cleared decision on January 30, 1991 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 K905773 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 1990
Decision Date January 30, 1991
Days to Decision 34 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
91d faster than avg
Panel avg: 125d · This submission: 34d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LIT Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - LIT Catheter, Angioplasty, Peripheral, Transluminal

All 250
Devices cleared under the same product code (LIT) and FDA review panel - the closest regulatory comparables to K905773.
MEADOX(R) SURGIMED OLBERT CATH SYST/NO PROFILE(TM)
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SCIMED OPTAMUM OPER PERIPHERAL ANGIOPLASTY CATH
K910155 · Scimed Life Systems, Inc. · Feb 1991
PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATH.
K902317 · Mallinckrodt Medical · Dec 1990
PE-MT 5 MEDI-TECH BALLOON DILATATION CATHETER
K900094 · Boston Scientific Corp · Oct 1990
MEDI-TECH DILATATION CATHETERS ULTRA THIN II
K897106 · Boston Scientific Corp · Oct 1990