Cleared Traditional

K941853 - PASSPORT

K941853 is the FDA 510(k) clearance for PASSPORT by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code EZN) cleared through the Traditional 510(k) pathway after a 151-day FDA review.

K941853 · Boston Scientific Corp · Gastroenterology & Urology device
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Sep 1994
Decision
151d
Days
Class 2
Risk

K941853 is an FDA 510(k) clearance for the PASSPORT. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Boston Scientific Corp (Watertown, US). The FDA issued a Cleared decision on September 12, 1994 after a review of 151 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K941853 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1994
Decision Date September 12, 1994
Days to Decision 151 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
21d slower than avg
Panel avg: 130d · This submission: 151d
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 K941853.
NOPROFILE OLBERT CATHETER SYSTEM BALLOON DILATION CATHETER
K953597 · Meadox Medicals, Div. Boston Scientific Corp. · Oct 1995
DILATATION CATHETER, BALLOON
K953004 · Boston Scientific Corp · Sep 1995
MEADOX SURGIMED NOPROFILE(TM) OLBERT CATHETER SYSTEM(R)
K945576 · Meadox Medicals, Div. Boston Scientific Corp. · Jan 1995
ENTRAC URETERAL BALLOON DILATATION CATHETERS
K942578 · American Medical Systems, Inc. · Aug 1994
NAMIC ARIA(TM) INFLATION DEVICE
K940542 · American Medical Systems, Inc. · Apr 1994
UROLOGICAL BALLOON DILATATION CATHETER
K935379 · Boston Scientific Corp · Feb 1994