Cleared Traditional

MULTILUMEN VIAPIC CENTRAL LINE CATHETER

K861510 · Warner-Lambert Co. · General Hospital
Jun 1986
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K861510 is an FDA 510(k) clearance for the MULTILUMEN VIAPIC CENTRAL LINE CATHETER, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Warner-Lambert Co. (Sandy, US). The FDA issued a Cleared decision on June 9, 1986, 47 days after receiving the submission on April 23, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K861510 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 1986
Decision Date June 09, 1986
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

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

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