The following data is part of a premarket notification filed by Greatbatch Medical with the FDA for Mobicath Bi-directional Guiding Sheath.
| Device ID | K130559 |
| 510k Number | K130559 |
| Device Name: | MOBICATH BI-DIRECTIONAL GUIDING SHEATH |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-03-04 |
| Decision Date | 2013-05-24 |