Cleared Traditional

MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S

K010021 · Medical Components, Inc. · General Hospital

Feb 2001

Decision

51d

Days

Class 2

Risk

About This 510(k) Submission

K010021 is an FDA 510(k) clearance for the MEDCOMP QUAD LUMEN, 8.5F X 20CM, MODEL MC4L-8S, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on February 23, 2001, 51 days after receiving the submission on January 3, 2001. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number	K010021 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 03, 2001
Decision Date	February 23, 2001
Days to Decision	51 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Summary PDF

Device Classification

Product Code	FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 880.5200