Cleared Traditional

K963397 - ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER

K963397 is an FDA 510(k) clearance for ULTRA-THIN DIAMOND BALLOON DILATATION C..., manufactured by Boston Scientific Corp. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K963397 · Boston Scientific Corp · Gastroenterology & Urology device
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Nov 1996
Decision
88d
Days
Class 2
Risk

K963397 is an FDA 510(k) clearance for the ULTRA-THIN DIAMOND BALLOON DILATATION CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on November 25, 1996 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - the FDA gastroenterology and urology device 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K963397

510(k) Number K963397 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1996
Decision Date November 25, 1996
Days to Decision 88 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 131d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 395
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K963397.
WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
K964119 · Boston Scientific Scimed, Inc. · Apr 1997
EXTRACTORRX
K970052 · Boston Scientific Corp · Mar 1997
COURIER BALLOON DILATATION CATHETER
K963691 · Boston Scientific Corp · Dec 1996
NAVARRE PERCUTANEOUS BILIARY DRAINAGE
K955110 · Navarre Biomedical , Ltd. · Nov 1996
OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
K962925 · Olympus America, Inc. · Oct 1996
DURAL-LUMEN INTRA VASCULAR BALLOON CATHETER (MODIFICATION)
K954713 · Ideas For Medicine, Inc. · Jul 1996