Cleared Traditional

K092597 - CENTROS CHRONIC HEMODIALYSIS CATHETER SET

K092597 is an FDA 510(k) clearance for CENTROS CHRONIC HEMODIALYSIS CATHETER SET, manufactured by Ash Access Technology, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K092597 · Ash Access Technology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2009
Decision
80d
Days
Class 2
Risk

K092597 is an FDA 510(k) clearance for the CENTROS CHRONIC HEMODIALYSIS CATHETER SET. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Ash Access Technology, Inc. (Lafayette, US). The FDA issued a Cleared decision on November 12, 2009 after a review of 80 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - 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 Ash Access Technology, Inc. devices

FDA 510(k) Submission Details - K092597

510(k) Number K092597 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 24, 2009
Decision Date November 12, 2009
Days to Decision 80 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 130d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MSD Device Classification - Class 2, Special Controls

Product Code MSD Catheter, Hemodialysis, Implanted
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
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 - MSD Catheter, Hemodialysis, Implanted

All 64
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K092597.
DURAFLOW 2 CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT
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DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM, DUET LONG-TERM HEMODIALYSIS CATHETER SYSTEM CATHETER REPAIR KIT
K090528 · C.R. Bard, Inc. · May 2009
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K090148 · Merit Medical Systems, Inc. · Apr 2009
EQUISTREAM LONG-TERM HEMODIALYSIS CATHETERS
K090101 · C.R. Bard, Inc. · Feb 2009