The following data is part of a premarket notification filed by Acumen Medical, Inc. with the FDA for 7f Acumen Coronary Sinus Visualization System, Model Csvs-7-67.
| Device ID | K062084 |
| 510k Number | K062084 |
| Device Name: | 7F ACUMEN CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS-7-67 |
| Classification | Catheter, Percutaneous |
| 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 | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-07-21 |
| Decision Date | 2006-08-18 |
| Summary: | summary |