Great Batch Medical · Class II · Cleared May 24, 2013
| K-number | K130559 |
| Device name | MOBICATH BI-DIRECTIONAL GUIDING SHEATH |
| Applicant | Great Batch Medical |
| Product code | DYB |
| Device class | Class II |
| Decision date | May 24, 2013 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
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