Cleared Abbreviated

K030020 - HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER

K030020 is the FDA 510(k) clearance for HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER by C.R. Bard, Inc.. It is a Class 2 Gastroenterology & Urology device (product code MSD) cleared through the Abbreviated 510(k) pathway after a 164-day FDA review.

K030020 · C.R. Bard, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
164d
Days
Class 2
Risk

K030020 is an FDA 510(k) clearance for the HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER. Classified as Catheter, Hemodialysis, Implanted (product code MSD), Class II - Special Controls.

Submitted by C.R. Bard, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on June 16, 2003 after a review of 164 days - an extended review 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all C.R. Bard, Inc. devices

Submission Details

510(k) Number K030020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2003
Decision Date June 16, 2003
Days to Decision 164 days
Submission Type Abbreviated
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
34d slower than avg
Panel avg: 130d · This submission: 164d
Pathway characteristics
Standards-based clearance path.

Device Classification

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 63
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K030020.
HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT
K033294 · C.R. Bard, Inc. · Nov 2003
VAXCEL PLUS CHRONIC DIALYSIS CATHETER
K032712 · Boston Scientific Corp · Oct 2003
SOFT-CELL DUAL LUMEN CATHETERS
K030277 · C.R. Bard, Inc. · Aug 2003
14.5F X 55CM HEMO-FLOW DOUBLE LUMEN CATHETER, MODELS HFS-55, HFT-55
K030502 · Medcomp · May 2003
DIATEK CANNON-CATHETER, MODEL CC5500
K022662 · Arrow Intl., Inc. · May 2003
MEDCOMP SC4
K022678 · Medcomp · Feb 2003