510(k) K926544

PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH by Pharmacia Deltec, Inc. — Product Code FOZ

K926544 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "PHARMACIA DELTEC PERIPHERALLY INSERTED VENOUS CATH". The FDA issued a decision of Substantially Equivalent on March 21, 1994. 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. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1994
Date Received
December 31, 1992
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