Cleared Special

SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM

K121848 · Medical Components, Inc. · Gastroenterology & Urology

Sep 2012

Decision

88d

Days

Class 2

Risk

About This 510(k) Submission

K121848 is an FDA 510(k) clearance for the SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM, a Catheter, Hemodialysis, Implanted (Class II — Special Controls, product code MSD), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on September 21, 2012, 88 days after receiving the submission on June 25, 2012. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5540.

Submission Details

510(k) Number	K121848 FDA.gov
FDA Decision	Cleared SESK
Date Received	June 25, 2012
Decision Date	September 21, 2012
Days to Decision	88 days
Submission Type	Special
Review Panel	Gastroenterology & Urology (GU)
Summary	Statement