Cleared Traditional

K953004 - DILATATION CATHETER

K953004 is the FDA 510(k) clearance for DILATATION CATHETER by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K953004 · Boston Scientific Corp · Gastroenterology & Urology device
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Sep 1995
Decision
77d
Days
Class 2
Risk

K953004 is an FDA 510(k) clearance for the DILATATION CATHETER, BALLOON. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on September 13, 1995 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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

Submission Details

510(k) Number K953004 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1995
Decision Date September 13, 1995
Days to Decision 77 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
53d faster than avg
Panel avg: 130d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 43
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K953004.
BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER
K962921 · C.R. Bard, Inc. · Oct 1996
MS CLASSIQUE BALLOON CATHETER W/HYDROPASS COATING
K953691 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1995
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER
K953597 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1995
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)
K945576 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1995
PASSPORT
K941853 · Boston Scientific Corp · Sep 1994
ENTRAC URETERAL BALLOON DILATATION CATHETERS
K942578 · American Medical Systems, Inc. · Aug 1994