Cleared Traditional

K973008 - COURIER ST BALLOON DILATATION CATHETER

K973008 is the FDA 510(k) clearance for COURIER ST BALLOON DILATATION CATHETER by Boston Scientific Corp. It is a Class 2 Gastroenterology & Urology device (product code FGE) cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K973008 · Boston Scientific Corp · Gastroenterology & Urology device
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Dec 1997
Decision
124d
Days
Class 2
Risk

K973008 is an FDA 510(k) clearance for the COURIER ST 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 December 15, 1997 after a review of 124 days - within the typical 510(k) review window.

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: 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 K973008 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1997
Decision Date December 15, 1997
Days to Decision 124 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
6d faster than avg
Panel avg: 130d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 298
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K973008.
MANAN VS ACCESS NEEDLE/SET
K980372 · Medical Device Technologies, Inc. · Apr 1998
MANAN BILIARY DRAINAGE CATHETER
K980191 · Medical Device Technologies, Inc. · Feb 1998
MANAN(TM) INTRODUCER SHEATH/NEEDLE
K974815 · Medical Device Technologies, Inc. · Jan 1998
URESIL GUIDEWIRE
K972582 · Uresil Corp. · Nov 1997
MODIFIED OLBERT BALLOON CATHETER SYSTEM, NOPROFILE OLBERT BALLOON CATHETER SYSTEM
K973113 · Boston Scientific Corp · Nov 1997
OPTA5 PTA BALLOON CATHETER, POWERFLEX PTA BALLOON CATHETER, ULTRA-THIN DIAMOND BALLOON CATHETER, PALMAZ BALLOON EXPANDAB
K972825 · Cordis Corp. · Oct 1997