The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Medamicus Coaxial Introducer Kit, 10330-xxx, Boston Scientific Coaxial Dilator Set.
| Device ID | K990705 |
| 510k Number | K990705 |
| Device Name: | MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET |
| Classification | Introducer, Catheter |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Dennis S Madison |
| Correspondent | Dennis S Madison MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-04 |
| Decision Date | 1999-06-28 |
| Summary: | summary |