The following data is part of a premarket notification filed by Medamicus, Inc. with the FDA for Percutaneous Venous Introducer 10264.
| Device ID | K965167 |
| 510k Number | K965167 |
| Device Name: | PERCUTANEOUS VENOUS INTRODUCER 10264 |
| 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 | 1996-12-24 |
| Decision Date | 1997-07-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10681490143766 | K965167 | 000 |
| 00681490142953 | K965167 | 000 |
| 10681490142943 | K965167 | 000 |
| 00681490142939 | K965167 | 000 |
| 00721902577451 | K965167 | 000 |
| 00721902577437 | K965167 | 000 |
| 00721902577413 | K965167 | 000 |
| 00721902577406 | K965167 | 000 |
| 10721902577304 | K965167 | 000 |
| 10721902577281 | K965167 | 000 |
| 10721902577274 | K965167 | 000 |
| 10721902577267 | K965167 | 000 |
| 00721902577192 | K965167 | 000 |
| 00721902577178 | K965167 | 000 |
| 00721902577161 | K965167 | 000 |
| 20643169646326 | K965167 | 000 |
| 00681490142960 | K965167 | 000 |
| 00681490143080 | K965167 | 000 |
| 10681490143094 | K965167 | 000 |
| 00681490143752 | K965167 | 000 |
| 10681490143735 | K965167 | 000 |
| 00681490143615 | K965167 | 000 |
| 10681490143599 | K965167 | 000 |
| 00681490143585 | K965167 | 000 |
| 00681490143448 | K965167 | 000 |
| 00681490143431 | K965167 | 000 |
| 10681490143421 | K965167 | 000 |
| 00681490143417 | K965167 | 000 |
| 00681490143288 | K965167 | 000 |
| 00681490143271 | K965167 | 000 |
| 10681490143261 | K965167 | 000 |
| 00681490143257 | K965167 | 000 |
| 00681490143110 | K965167 | 000 |
| 00681490143103 | K965167 | 000 |
| 00643169646209 | K965167 | 000 |