The following data is part of a premarket notification filed by Greatbatch Medical with the FDA for Mobicath Bi-directional Guiding Sheath Model 1000182-xxx.
| Device ID | K101784 |
| 510k Number | K101784 |
| Device Name: | MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX |
| Classification | Introducer, Catheter |
| Applicant | Greatbatch Medical 2300 BERKSHIRE LANE NORTH Minneapolis, MN 55441 |
| Contact | Kristi Fox |
| Correspondent | Kristi Fox 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 | 2010-06-25 |
| Decision Date | 2010-11-26 |
| Summary: | summary |