Acumen Medical, Inc. · Class II · Cleared May 22, 2007
| K-number | K070396 |
| Device name | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45 |
| Applicant | Acumen Medical, Inc. |
| Product code | DYB |
| Device class | Class II |
| Decision date | May 22, 2007 |
| Decision | Substantially Equivalent |
| Regulation | 870.1340 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov