The following data is part of a premarket notification filed by Acumen Medical, Inc. with the FDA for Modification To: Acumen Single-lumen Delivery Sheath, Models Bls-10, Bls-9, Bls-7.
| Device ID | K080500 |
| 510k Number | K080500 |
| Device Name: | MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 |
| Classification | Introducer, Catheter |
| Applicant | ACUMEN MEDICAL, INC. 275 SANTA ANA COURT Sunnyvale, CA 94085 |
| Contact | Kevin Macdonald |
| Correspondent | Kevin Macdonald ACUMEN MEDICAL, INC. 275 SANTA ANA COURT Sunnyvale, CA 94085 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-02-25 |
| Decision Date | 2008-03-13 |
| Summary: | summary |