The following data is part of a premarket notification filed by Sims Deltec, Inc. with the FDA for Port-a-cath Ii Venous Implantable Access Systems Preconnected With Polyurethane Catheter.
| Device ID | K962695 |
| 510k Number | K962695 |
| Device Name: | PORT-A-CATH II VENOUS IMPLANTABLE ACCESS SYSTEMS PRECONNECTED WITH POLYURETHANE CATHETER |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SIMS DELTEC, INC. 1265 GREY FOX RD. St. Paul, MN 55112 |
| Contact | Lisa J Stone |
| Correspondent | Lisa J 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 | 1996-07-11 |
| Decision Date | 1996-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10610586039935 | K962695 | 000 |
| 10610586023552 | K962695 | 000 |
| 10610586023576 | K962695 | 000 |
| 10610586023583 | K962695 | 000 |
| 10610586023620 | K962695 | 000 |
| 10610586023866 | K962695 | 000 |
| 10610586039904 | K962695 | 000 |
| 10610586039911 | K962695 | 000 |
| 10610586039928 | K962695 | 000 |
| 10610586021985 | K962695 | 000 |