The following data is part of a premarket notification filed by Greatbatch Medical with the FDA for Mobicath Transseptal Needle.
| Device ID | K122832 |
| 510k Number | K122832 |
| Device Name: | MOBICATH TRANSSEPTAL NEEDLE |
| Classification | Trocar |
| Applicant | Greatbatch Medical 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Contact | Denise Thompson |
| Correspondent | Denise Thompson Greatbatch Medical 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-09-17 |
| Decision Date | 2012-12-19 |
| Summary: | summary |