The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Dual Lumen Peripherally Inserted Venous Catheter.
Device ID | K932430 |
510k Number | K932430 |
Device Name: | DUAL LUMEN PERIPHERALLY INSERTED VENOUS CATHETER |
Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | Edward Numainville |
Correspondent | Edward Numainville PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Product Code | LJS |
CFR Regulation Number | 880.5970 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-20 |
Decision Date | 1994-05-02 |