510(k) K895597

VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER by Vas-Cath, Inc. — Product Code FOZ

K895597 is an FDA 510(k) premarket notification submitted by Vas-Cath, Inc. for the device "VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER". The FDA issued a decision of Substantially Equivalent on September 12, 1990. The device falls under product code FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days), a Class II device regulated under 21 CFR 880.5200. Vas-Cath, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 12, 1990
Date Received
September 18, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type