The following data is part of a premarket notification filed by Shiley Infusaid, Inc. with the FDA for Polyurethane Catheter For The Infuse-a-port.
| Device ID | K872898 |
| 510k Number | K872898 |
| Device Name: | POLYURETHANE CATHETER FOR THE INFUSE-A-PORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | SHILEY INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Contact | Nancy C Hall |
| Correspondent | Nancy C Hall SHILEY INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-23 |
| Decision Date | 1987-09-15 |