The following data is part of a premarket notification filed by Atrium Medical Corporation with the FDA for Auto Transfusion (ats) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain.
| Device ID | K201305 |
| 510k Number | K201305 |
| Device Name: | Auto Transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain |
| Classification | Apparatus, Autotransfusion |
| Applicant | Atrium Medical Corporation 40 Continental Blvd. Merrimack, NH 03054 |
| Contact | Robin Mulvey |
| Correspondent | Robin Mulvey Atrium Medical Corporation 40 Continental Blvd. Merrimack, NH 03054 |
| Product Code | CAC |
| CFR Regulation Number | 868.5830 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-15 |
| Decision Date | 2021-09-03 |