The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Port-a-cath Implantable Vascular Access System.
Device ID | K932840 |
510k Number | K932840 |
Device Name: | PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM |
Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Contact | David Short |
Correspondent | David Short PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
Product Code | LJT |
CFR Regulation Number | 880.5965 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-06-11 |
Decision Date | 1994-01-05 |