Cleared Traditional

K914617 - CATHETER

K914617 is the FDA 510(k) clearance for 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 64-day FDA review.

K914617 · Boston Scientific Corp · Gastroenterology & Urology device
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Dec 1991
Decision
64d
Days
Class 2
Risk

K914617 is an FDA 510(k) clearance for the CATHETER, URETERAL DILATOR. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Boston Scientific Corp (San Jose, US). The FDA issued a Cleared decision on December 20, 1991 after a review of 64 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 K914617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 17, 1991
Decision Date December 20, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 130d · This submission: 64d
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 K914617.
ENTRAC URETERAL BALLOON DILATION CATHETERS
K921839 · American Medical Systems, Inc. · Oct 1992
UROLOGICAL BALLOON DILATATION CATHETER
K920946 · Boston Scientific Corp · Jul 1992
ACCENT DG BALLOON URTERAL DILATOR SET, 10CM
K915392 · Cook Urological, Inc. · Mar 1992
URS-HYDRO-DILATOR MODEL NUMBER 2164.00
K912331 · Richard Wolf Medical Instruments Corp. · Oct 1991
ACCENT DG BALLOON URETERAL DILATOR SET
K905375 · Cook Urological, Inc. · Apr 1991
URETERAL BALLOON DILATATION CATHETER
K903813 · Boston Scientific Corp · Nov 1990