510(k) K952201

PORT-A-CATH ACCESS KIT by Medi-Flex Hospital Products, Inc. — Product Code FMF

K952201 is an FDA 510(k) premarket notification submitted by Medi-Flex Hospital Products, Inc. for the device "PORT-A-CATH ACCESS KIT". The FDA issued a decision of Substantially Equivalent on October 4, 1995. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Medi-Flex Hospital Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 4, 1995
Date Received
May 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type