Acumen Medical, Inc. · Class II · Cleared Aug 23, 2006
| K-number | K062145 |
| Device name | MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90 |
| Applicant | Acumen Medical, Inc. |
| Product code | DYB |
| Device class | Class II |
| Decision date | Aug 23, 2006 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
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