The following data is part of a premarket notification filed by Greatbatch Medical with the FDA for Z Flex-270tm Steerable Sheath.
| Device ID | K112541 |
| 510k Number | K112541 |
| Device Name: | Z FLEX-270TM STEERABLE SHEATH |
| Classification | Catheter, Steerable |
| 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 | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-01 |
| Decision Date | 2012-02-07 |
| Summary: | summary |