Cleared Traditional

SECONDARY SET LOCK

K864338 · Travenol Laboratories, S.A. · General Hospital
Nov 1986
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K864338 is an FDA 510(k) clearance for the SECONDARY SET LOCK, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Travenol Laboratories, S.A. (Deerfield, US). The FDA issued a Cleared decision on November 19, 1986, 15 days after receiving the submission on November 4, 1986. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K864338 FDA.gov
FDA Decision Cleared SESE
Date Received November 04, 1986
Decision Date November 19, 1986
Days to Decision 15 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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