The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Port-a-cath Dual Lumen Implantable Venous Access S.
| Device ID | K932095 |
| 510k Number | K932095 |
| Device Name: | PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | David H Short |
| Correspondent | David H 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 | 1993-04-30 |
| Decision Date | 1994-01-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586024481 | K932095 | 000 |
| 10610586023873 | K932095 | 000 |