The following data is part of a premarket notification filed by Greatbatch Medical with the FDA for Radialseal Introducer Kit.
| Device ID | K181855 |
| 510k Number | K181855 |
| Device Name: | RadialSeal Introducer Kit |
| Classification | Introducer, Catheter |
| Applicant | Greatbatch Medical 2300 Berkshire Lane North Minneapolis, MN 55441 |
| Contact | Phyllis Piet-hughes |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-07-11 |
| Decision Date | 2018-07-26 |
| Summary: | summary |