Cleared Traditional

K970661 - CA CELLULOSE ACETATE HOLLOW FIBER DIALY...

K970661 is the FDA 510(k) clearance for CA CELLULOSE ACETATE HOLLOW FIBER DIALY... by Baxter Healthcare Corp. It is a Class 2 Gastroenterology & Urology device (product code MSE) cleared through the Traditional 510(k) pathway after a 264-day FDA review.

K970661 · Baxter Healthcare Corp · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1997
Decision
264d
Days
Class 2
Risk

K970661 is an FDA 510(k) clearance for the CA CELLULOSE ACETATE HOLLOW FIBER DIALYZER (CA-90). Classified as Hemodialyzer, Re-use, Low Flux (product code MSE), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on November 12, 1997 after a review of 264 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5820 - 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number K970661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1997
Decision Date November 12, 1997
Days to Decision 264 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
134d slower than avg
Panel avg: 130d · This submission: 264d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MSE Hemodialyzer, Re-use, Low Flux
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5820
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 - MSE Hemodialyzer, Re-use, Low Flux

Devices cleared under the same product code (MSE) and FDA review panel - the closest regulatory comparables to K970661.
FRESENIUS POLYSULFONE HEMODIALYZERS, BOTH LOW AND HIGH FLUX
K970700 · Fresenius USA, Inc. · Sep 1998
95 C/1.5 CITRIC ACID HEAT PROCESSING OF POLYSULFONE DIALYZERS
K974090 · Fresenius Medical Care North America · Aug 1998
CAHP HIGH PERFORMANCE CELLULOSE DIACETATE (CAPILLARY, HOLLOW FIBER)
K970654 · Baxter Healthcare Corp · Nov 1997