510(k) K974363

BECTON DICKINSON BLUNT PLASTIC CANNULA by Bd Becton Dickinson Vacutainer Systems Preanalytic — Product Code FMI

K974363 is an FDA 510(k) premarket notification submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic for the device "BECTON DICKINSON BLUNT PLASTIC CANNULA". The FDA issued a decision of Substantially Equivalent on June 3, 1998. The device falls under product code FMI (Needle, Hypodermic, Single Lumen), a Class II device regulated under 21 CFR 880.5570. Bd Becton Dickinson Vacutainer Systems Preanalytic has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 3, 1998
Date Received
November 19, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Needle, Hypodermic, Single Lumen
Device Class
Class II
Regulation Number
880.5570
Review Panel
HO
Submission Type