510(k) K961155

SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908 by Douglas Medical Products Corp. — Product Code LJS

K961155 is an FDA 510(k) premarket notification submitted by Douglas Medical Products Corp. for the device "SOLO PICC/MIDLINE CATHETER KIT MODELS 71924, 71908". The FDA issued a decision of Substantially Equivalent on June 18, 1996. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. Douglas Medical Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 1996
Date Received
March 22, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type