Cleared Traditional

LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT (K964688) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K964688 · Cordis Corp. · Gastroenterology & Urology device
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Jun 1997
Decision
210d
Days
Class 2
Risk

K964688 is an FDA 510(k) clearance for the LONG MEDIUM PALMAZ-SCHATZ BALLOON EXPANDABLE STENT. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on June 20, 1997 after a review of 210 days - an extended review 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: 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 Cordis Corp. devices

Submission Details

510(k) Number K964688 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1996
Decision Date June 20, 1997
Days to Decision 210 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
80d slower than avg
Panel avg: 130d · This submission: 210d
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 213
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K964688.
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
BILIARY STENT, BILIARY STENT SYSTEM, BILIARY ENDOPROSTHESIS
K965147 · Boston Scientific Corp · Jun 1997
SYMPHONY NITINOL STENT TRANSHEPATIC BILIARY SYSTEM
K963254 · Boston Scientific Corp · May 1997
ULTRAFLEX DIAMOND
K962899 · Boston Scientific Corp · May 1997
BARD MEMOTHERM TRANSHEPATIC BILIARY ENDOPROSTHESIS
K963782 · C.R. Bard, Inc. · May 1997