The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Plastic Port Implantable Venous Access System.
| Device ID | K994216 |
| 510k Number | K994216 |
| Device Name: | PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM |
| 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 | 1999-12-15 |
| Decision Date | 2000-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00610586012665 | K994216 | 000 |
| 10610586012716 | K994216 | 000 |
| 10610586012693 | K994216 | 000 |
| 10610586012686 | K994216 | 000 |
| 10610586012594 | K994216 | 000 |
| 10610586012570 | K994216 | 000 |
| 10610586012563 | K994216 | 000 |
| 10610586012549 | K994216 | 000 |
| 10610586012532 | K994216 | 000 |
| 10610586012723 | K994216 | 000 |
| 10610586012747 | K994216 | 000 |
| 00610586012658 | K994216 | 000 |
| 00610586012634 | K994216 | 000 |
| 10610586012839 | K994216 | 000 |
| 10610586012815 | K994216 | 000 |
| 10610586012808 | K994216 | 000 |
| 10610586012785 | K994216 | 000 |
| 10610586012778 | K994216 | 000 |
| 10610586012754 | K994216 | 000 |
| 10610586012518 | K994216 | 000 |