510(k) K832332

VENTED I.V. TRANSFER NEEDLE by Baxa Corp., Sub. of Cook Group, Inc. — Product Code LHI

K832332 is an FDA 510(k) premarket notification submitted by Baxa Corp., Sub. of Cook Group, Inc. for the device "VENTED I.V. TRANSFER NEEDLE". The FDA issued a decision of Substantially Equivalent on September 12, 1983. The device falls under product code LHI (Set, I.V. Fluid Transfer), a Class II device regulated under 21 CFR 880.5440. Baxa Corp., Sub. of Cook Group, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1983
Date Received
July 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, I.V. Fluid Transfer
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type