510(k) K932211

PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS by Pharmacia Deltec, Inc. — Product Code LJS

K932211 is an FDA 510(k) premarket notification submitted by Pharmacia Deltec, Inc. for the device "PROCEDURAL TRAY FOR PERIPHERALLY INSERTED VENOUS". The FDA issued a decision of Substantially Equivalent on May 2, 1994. 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. Pharmacia Deltec, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 2, 1994
Date Received
May 7, 1993
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