The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Percutaneous Introducer, Model 10383-xxx.
| Device ID | K000824 |
| 510k Number | K000824 |
| Device Name: | PERCUTANEOUS INTRODUCER, MODEL 10383-XXX |
| Classification | Introducer, Catheter |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | Dennis Madison |
| Correspondent | Dennis Madison MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-03-14 |
| Decision Date | 2000-04-13 |