Cleared Special

K021212 - 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS

K021212 is an FDA 510(k) clearance for 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONI..., manufactured by Spire Biomedical, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code MSD cleared through the Special 510(k) pathway after a 30-day FDA review.

K021212 · Spire Biomedical, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
30d
Days
Class 2
Risk

K021212 is an FDA 510(k) clearance for the 24CM POURCHEZ XPRESSO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED.... Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by Spire Biomedical, Inc. (Bedford, US). The FDA issued a Cleared decision on May 17, 2002 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Spire Biomedical, Inc. devices

FDA 510(k) Submission Details - K021212

510(k) Number K021212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2002
Decision Date May 17, 2002
Days to Decision 30 days
Submission Type Special
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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 K021212.
POURCHEZ RETRO TWIN LUMEN CHRONIC HEMODIALYSIS CATHETER WITH SEPARATED TIPS (WITH AND WITHOUT SIDE HOLES)
K022000 · Spire Biomedical, Inc. · Jul 2002
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K020315 · Medcomp · May 2002
MEDCOMP ASH SPLIT-CATH II
K020465 · Medcomp · May 2002
POURCHEZ XPRESSO TWIN LIMEN CHRONIC HEMODIALYSIS CATHETER
K013160 · Spire Biomedical, Inc. · Apr 2002
MEDCOMP 14.5F DOUBLE LUMEN HEMODIALYSIS CATHETER
K012562 · Medical Components, Inc. · Feb 2002
SUPER C HEMODIALYSIS/APHERESIS CHRONIC CATHETER, MODEL DC-36 SERIES, DC-40 SERIES, DC-45 SERIES
K011916 · Horizon Medical Products, Inc. · Oct 2001