The following data is part of a premarket notification filed by Gerard Medical, Inc. with the FDA for Trimport.
| Device ID | K974533 |
| 510k Number | K974533 |
| Device Name: | TRIMPORT |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | GERARD MEDICAL, INC. 6 CITY DEPOT RD. Charlton City, MA 01508 |
| Contact | Richard Cayer |
| Correspondent | Richard Cayer GERARD MEDICAL, INC. 6 CITY DEPOT RD. Charlton City, MA 01508 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-12-02 |
| Decision Date | 1998-05-07 |
| Summary: | summary |