Cleared Traditional

K905720 - PALMAZ BILIARY STENT

K905720 is an FDA 510(k) clearance for PALMAZ BILIARY STENT, manufactured by Johnson & Johnson Interventional Systems. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K905720 · Johnson & Johnson Interventional Systems · Cardiovascular device
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Feb 1991
Decision
46d
Days
Class 2
Risk

K905720 is an FDA 510(k) clearance for the PALMAZ BILIARY STENT. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Johnson & Johnson Interventional Systems (Warren, US). The FDA issued a Cleared decision on February 5, 1991 after a review of 46 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 Johnson & Johnson Interventional Systems devices

FDA 510(k) Submission Details - K905720

510(k) Number K905720 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1990
Decision Date February 05, 1991
Days to Decision 46 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 125d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQY Device Classification - Class 2, Special Controls

Product Code DQY Catheter, Percutaneous
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 - DQY Catheter, Percutaneous

All 601
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K905720.
NEW USCI 7F PTCA GUIDING CATHETER
K905249 · C.R. Bard, Inc. · Feb 1991
MULTI-LUMEN CENTRAL VENOUS CATHETER SET
K904404 · Arrow Intl., Inc. · Feb 1991
SOFTOUCH GUIDING CATHETER
K905547 · Mallinckrodt Medical · Feb 1991
VASCULAR RETRIEVAL FORCEPS
K902999 · Cook, Inc. · Feb 1991
ACS URETHAN CORONARY GUIDING CATHETER
K904884 · Advanced Cardiovascular Systems, Inc. · Jan 1991
MALLINCKRODT MEDICAL, INC., INFUSSION CATHERTER
K903330 · Mallinckrodt Medical · Oct 1990