Cleared Traditional

VCI SUCTION/IRRIGATION TUBING SET

K934382 · Vital Concepts, Inc. · General Hospital
Feb 1994
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K934382 is an FDA 510(k) clearance for the VCI SUCTION/IRRIGATION TUBING SET, a Catheter And Tip, Suction (Class II — Special Controls, product code JOL), submitted by Vital Concepts, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on February 1, 1994, 145 days after receiving the submission on September 9, 1993. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6740.

Submission Details

510(k) Number K934382 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1993
Decision Date February 01, 1994
Days to Decision 145 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code JOL — Catheter And Tip, Suction
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.6740

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