The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Medamicus Percutaneous Introducer.
| Device ID | K951313 |
| 510k Number | K951313 |
| Device Name: | MEDAMICUS PERCUTANEOUS INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | MEDAMICUS, INC. 15301 HWY. 55 WEST Minneapolis, MN 55447 |
| Contact | David A Liebl |
| Correspondent | David A Liebl 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 | 1995-03-23 |
| Decision Date | 1995-06-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20643169646333 | K951313 | 000 |
| 00643169646162 | K951313 | 000 |
| 00643169646179 | K951313 | 000 |
| 00643169646186 | K951313 | 000 |
| 00643169646193 | K951313 | 000 |
| 00643169646216 | K951313 | 000 |
| 20643169646272 | K951313 | 000 |
| 20643169646289 | K951313 | 000 |
| 20643169646296 | K951313 | 000 |
| 20643169646302 | K951313 | 000 |
| 20643169646319 | K951313 | 000 |
| 00643169646155 | K951313 | 000 |