The following data is part of a premarket notification filed by Intermedics/infusaid, Inc. with the FDA for Infusaid Infuse-a-port (modified).
| Device ID | K853981 |
| 510k Number | K853981 |
| Device Name: | INFUSAID INFUSE-A-PORT (MODIFIED) |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | INTERMEDICS/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Contact | Vincent A Bucci |
| Correspondent | Vincent A Bucci INTERMEDICS/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 | 1985-09-27 |
| Decision Date | 1985-12-18 |