Cleared Abbreviated

SOFT-CELL DUAL LUMEN CATHETERS (K030277) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K030277 · C.R. Bard, Inc. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 2003
Decision
191d
Days
Class 2
Risk

K030277 is an FDA 510(k) clearance for the SOFT-CELL DUAL LUMEN CATHETERS. 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 August 6, 2003 after a review of 191 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 K030277 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 2003
Decision Date August 06, 2003
Days to Decision 191 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
61d slower than avg
Panel avg: 130d · This submission: 191d
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 123
Devices cleared under the same product code (MSD) and FDA review panel - the closest regulatory comparables to K030277.
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K203767 · C B Bard, Inc. · Apr 2021
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K202150 · C.R. Bard, Inc. · Nov 2020