The following data is part of a premarket notification filed by Medi-tech, Inc. with the FDA for Medi-tech Eddy Intravascular Infusion Catheter.
| Device ID | K954457 |
| 510k Number | K954457 |
| Device Name: | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | MEDI-TECH, INC. One Boston Scientific Place Natick, MA 01760 |
| Contact | Darlene A Thometz |
| Correspondent | Darlene A Thometz MEDI-TECH, INC. One Boston Scientific Place Natick, MA 01760 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-25 |
| Decision Date | 1996-05-15 |
| Summary: | summary |