Cleared Special

MEDCOMP ASH SPLIT

K011576 · Medical Components, Inc. · Gastroenterology & Urology

Jun 2001

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K011576 is an FDA 510(k) clearance for the MEDCOMP ASH SPLIT, a Kit, Repair, Catheter, Hemodialysis (Class II — Special Controls, product code NFK), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on June 21, 2001, 30 days after receiving the submission on May 22, 2001. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K011576 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 22, 2001
Decision Date	June 21, 2001
Days to Decision	30 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Summary PDF

Device Classification

Product Code	NFK — Kit, Repair, Catheter, Hemodialysis
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 876.5540
Definition	Hemodialysis Tray