The following data is part of a premarket notification filed by Intermedics/infusaid, Inc. with the FDA for Infuse-a-port Explant Kit.
| Device ID | K863296 |
| 510k Number | K863296 |
| Device Name: | INFUSE-A-PORT EXPLANT KIT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | INTERMEDICS/INFUSAID, INC. 1400 PROVIDENCE HIGHWAY Norwood, MA 02062 |
| Contact | Nancy C Hall |
| Correspondent | Nancy C Hall 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 | 1986-08-25 |
| Decision Date | 1986-09-11 |