The following data is part of a premarket notification filed by Pharmacia Deltec, Inc. with the FDA for Port-a-cath Low Profile Implantable Venous Access System.
| Device ID | K942024 |
| 510k Number | K942024 |
| Device Name: | PORT-A-CATH LOW PROFILE IMPLANTABLE VENOUS ACCESS SYSTEM |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | PHARMACIA DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa J Stone |
| Correspondent | Lisa J Stone 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 | 1994-04-26 |
| Decision Date | 1994-07-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586025228 | K942024 | 000 |
| 10610586017841 | K942024 | 000 |
| 10610586017872 | K942024 | 000 |
| 10610586018329 | K942024 | 000 |
| 10610586023613 | K942024 | 000 |
| 10610586023859 | K942024 | 000 |
| 10610586025167 | K942024 | 000 |
| 10610586025174 | K942024 | 000 |
| 10610586025204 | K942024 | 000 |
| 10610586025211 | K942024 | 000 |
| 10610586017827 | K942024 | 000 |