510(k) K905189

BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL) by Baxter Healthcare Corp — Product Code DQI

K905189 is an FDA 510(k) premarket notification submitted by Baxter Healthcare Corp for the device "BAXTER ANGIOSCOPY PUMP TUBING SET (MODEL NL)". The FDA issued a decision of Substantially Equivalent on January 30, 1991. The device falls under product code DQI (Withdrawal/Infusion Pump), a Class II device regulated under 21 CFR 870.1800. Baxter Healthcare Corp has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1991
Date Received
November 19, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Withdrawal/Infusion Pump
Device Class
Class II
Regulation Number
870.1800
Review Panel
HO
Submission Type