Cleared Traditional

CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE

K873894 · Travenol Laboratories, S.A. · General Hospital
Nov 1987
Decision
42d
Days
Class 2
Risk

About This 510(k) Submission

K873894 is an FDA 510(k) clearance for the CONTINU-FLO SOLUTION W/CHECK VALVE 2 Y-INJECT SITE, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Travenol Laboratories, S.A. (Round Lake, US). The FDA issued a Cleared decision on November 5, 1987, 42 days after receiving the submission on September 24, 1987. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K873894 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1987
Decision Date November 05, 1987
Days to Decision 42 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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