Cleared Traditional

BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)

K905189 · Baxter Healthcare Corp · General Hospital
Jan 1991
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K905189 is an FDA 510(k) clearance for the BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL), a Withdrawal/infusion Pump (Class II — Special Controls, product code DQI), submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on January 30, 1991, 72 days after receiving the submission on November 19, 1990. This device falls under the General Hospital review panel. Regulated under 21 CFR 870.1800.

Submission Details

510(k) Number K905189 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1990
Decision Date January 30, 1991
Days to Decision 72 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary —

Device Classification

Product Code DQI — Withdrawal/infusion Pump
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1800

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