510(k) K020333

ATRION MEDICAL QL FLUID DISPENSING SYRINGE by Atrion Medical Products, Inc. — Product Code DXT

K020333 is an FDA 510(k) premarket notification submitted by Atrion Medical Products, Inc. for the device "ATRION MEDICAL QL FLUID DISPENSING SYRINGE". The FDA issued a decision of Substantially Equivalent on April 25, 2002. The device falls under product code DXT (Injector And Syringe, Angiographic), a Class II device regulated under 21 CFR 870.1650. Atrion Medical Products, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 25, 2002
Date Received
January 31, 2002
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