The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Port-a-cath Low-profile Implantable Access Systems.
| Device ID | K973862 |
| 510k Number | K973862 |
| Device Name: | PORT-A-CATH LOW-PROFILE IMPLANTABLE ACCESS SYSTEMS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa Stone |
| Correspondent | Lisa Stone SIMS 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 | 1997-10-09 |
| Decision Date | 1997-12-29 |
| Summary: | summary |