Cleared Traditional

K070572 - ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS

Also marketed or referenced as:
15FR X 24CM, 15FR X 28CM, 15FR X 32CM

K070572 is an FDA 510(k) clearance for ASH ADVANCE HEMODIALYSIS CATHETER AND P..., 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 118-day FDA review.

K070572 · Ash Access Technology, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2007
Decision
118d
Days
Class 2
Risk

K070572 is an FDA 510(k) clearance for the ASH ADVANCE HEMODIALYSIS CATHETER AND PROCEDURE KIT, MODELS. 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 June 26, 2007 after a review of 118 days - within the typical 510(k) review window.

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: 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 Ash Access Technology, Inc. devices

FDA 510(k) Submission Details - K070572

510(k) Number K070572 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received February 28, 2007
Decision Date June 26, 2007
Days to Decision 118 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
13d faster than avg
Panel avg: 131d · This submission: 118d
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 112
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K070572.
DERMAPORT PERCUTANEOUS VASCULAR ACCESS SYSTEM (PVAS)
K071202 · Dermaport, Inc. · Nov 2007
NOVOFLO CATHETER LT
K072499 · Novosci, Inc. · Oct 2007
15.5F HEMO-STREAM HEMODIALYSIS CATHETER SET
K071422 · Rex Medical · Aug 2007
15.5FR ALTA GOLD, COATED HEMODIALYSIS CATHETER, MODEL ALC19SH24, ALC23SH28, ALC27SH32, ALC31SH36, ALC35SH40, ALC50SH55
K063441 · Spire Biomedical, Inc. · Feb 2007
HEMOCATH II
K062901 · Med-Conduit, Inc. · Feb 2007
15.5 FR DECATHLON GOLD, FUNNEL TIPS, COATED HEMODIALYSIS CATHETER, DFC19SH24, DFC23SH28, DFC27SH32, DFC31SH36, DFC35SH40
K063431 · Spire Biomedical, Inc. · Jan 2007