The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Guidewire Introducer Safety Needle.
| Device ID | K011085 |
| 510k Number | K011085 |
| Device Name: | GUIDEWIRE INTRODUCER SAFETY NEEDLE |
| 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 | 2001-04-10 |
| Decision Date | 2001-07-09 |