Cleared Traditional

K910493 - AVD INTIMAX CHOLANGIOGRAPHY CATHETER

K910493 is an FDA 510(k) clearance for AVD INTIMAX CHOLANGIOGRAPHY CATHETER, manufactured by Applied Vascular Devices, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K910493 · Applied Vascular Devices, Inc. · Gastroenterology & Urology device
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Mar 1991
Decision
51d
Days
Class 2
Risk

K910493 is an FDA 510(k) clearance for the AVD INTIMAX CHOLANGIOGRAPHY CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Applied Vascular Devices, Inc. (Laguna Hills, US). The FDA issued a Cleared decision on March 28, 1991 after a review of 51 days - a notably fast clearance 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: 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 Applied Vascular Devices, Inc. devices

FDA 510(k) Submission Details - K910493

510(k) Number K910493 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1991
Decision Date March 28, 1991
Days to Decision 51 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 131d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

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 400
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K910493.
DRAINAGE CATHETERS W/A DISSOLVABLE TIP
K900205 · Boston Scientific Corp · Aug 1991
MODEL GS-4700 COMMON DUCT STONE REMOVING KIT
K910671 · Solos Endoscopy, Inc. · May 1991
BILIARY BALLOON DILATATION CATHETER
K910931 · Boston Scientific Corp · Apr 1991
OPERATIVE CHOLANGIOGRAPHIC CATHETER
K905738 · Applied Vascular Devices, Inc. · Mar 1991
BALLOON CATHETERS
K904669 · Olympus Corp. · Mar 1991
BAXTER LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERS
K905707 · Baxter Healthcare Corp · Feb 1991