The following data is part of a premarket notification filed by Acumen Medical, Inc. with the FDA for Modified Acumen Sheath, Model Ttwo767.
| Device ID | K050015 |
| 510k Number | K050015 |
| Device Name: | MODIFIED ACUMEN SHEATH, MODEL TTWO767 |
| Classification | Introducer, Catheter |
| Applicant | ACUMEN MEDICAL, INC. 1400 TERRA BELLA BLVD. SUITE A Mountain View, CA 94043 |
| Contact | Marybeth Gamber |
| Correspondent | Marybeth Gamber ACUMEN MEDICAL, INC. 1400 TERRA BELLA BLVD. SUITE A Mountain View, CA 94043 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-04 |
| Decision Date | 2005-02-03 |
| Summary: | summary |