510(k) K873955

NAMIC ANGIOGRAPHIC SYRINGE by North American Instrument Corp. — Product Code DXT

K873955 is an FDA 510(k) premarket notification submitted by North American Instrument Corp. for the device "NAMIC ANGIOGRAPHIC SYRINGE". The FDA issued a decision of Substantially Equivalent on February 5, 1988. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. North American Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 5, 1988
Date Received
September 28, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Injector And Syringe, Angiographic
Device Class
Class II
Regulation Number
870.1650
Review Panel
HO
Submission Type