The following data is part of a premarket notification filed by Acumen Medical, Inc. with the FDA for Acumen Single-lumen Delivery Sheath.
| Device ID | K053400 |
| 510k Number | K053400 |
| Device Name: | ACUMEN SINGLE-LUMEN DELIVERY SHEATH |
| Classification | Introducer, Catheter |
| Applicant | ACUMEN MEDICAL, INC. 275 SANTA ANA COURT Sunnyvale, CA 94085 |
| Contact | Marybeth Gamber |
| Correspondent | Marybeth Gamber ACUMEN MEDICAL, INC. 275 SANTA ANA COURT Sunnyvale, CA 94085 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-06 |
| Decision Date | 2006-06-19 |
| Summary: | summary |