Cleared Traditional

11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT

K980438 · Medical Components, Inc. · Gastroenterology & Urology
Jun 1999
Decision
491d
Days
Class 2
Risk

About This 510(k) Submission

K980438 is an FDA 510(k) clearance for the 11.5F X 6 (15CM) DUO-SPLIT CATHETER MCDS116MT, 11.5F X 8 (20CM) DUO-SPLIT CATHETER MCDS118MT, a Catheter, Hemodialysis, Non-implanted (Class II — Special Controls, product code MPB), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on June 10, 1999, 491 days after receiving the submission on February 4, 1998. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number K980438 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1998
Decision Date June 10, 1999
Days to Decision 491 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement

Device Classification

Product Code MPB — Catheter, Hemodialysis, Non-implanted
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5540

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