510(k) K900187

ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH) by Advance Medical Designs, Inc. — Product Code FPA

K900187 is an FDA 510(k) premarket notification submitted by Advance Medical Designs, Inc. for the device "ADVANCE CONTRAST MEDIA SETS (VARYING LENGTH)". The FDA issued a decision of Substantially Equivalent on May 1, 1990. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Advance Medical Designs, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1990
Date Received
January 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type