510(k) K930854

SOLUTION SET WITH .2 MICRON FILTER by Douglas Medical Products Corp. — Product Code FPA

K930854 is an FDA 510(k) premarket notification submitted by Douglas Medical Products Corp. for the device "SOLUTION SET WITH .2 MICRON FILTER". The FDA issued a decision of Substantially Equivalent on January 14, 1994. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Douglas Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 14, 1994
Date Received
February 18, 1993
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