The following data is part of a premarket notification filed by Greatbatch Medical with the FDA for Radialsource Transradial Access Introducer Kit.
| Device ID | K110051 |
| 510k Number | K110051 |
| Device Name: | RADIALSOURCE TRANSRADIAL ACCESS INTRODUCER KIT |
| Classification | Introducer, Catheter |
| Applicant | Greatbatch Medical 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Contact | Sara Bakker |
| Correspondent | Sara Bakker Greatbatch Medical 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-01-07 |
| Decision Date | 2012-02-02 |
| Summary: | summary |