The following data is part of a premarket notification filed by Century Hlm, Llc with the FDA for Century Perfusion System.
| Device ID | K202125 |
| 510k Number | K202125 |
| Device Name: | Century Perfusion System |
| Classification | Console, Heart-lung Machine, Cardiopulmonary Bypass |
| Applicant | Century HLM, LLC 3110 N. Oakland, STE 101 Mesa, AZ 85215 |
| Contact | Jeff Poland |
| Correspondent | Vaibhav Arvind Rajal mdi Consultants,Inc. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | DTQ |
| CFR Regulation Number | 870.4220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-31 |
| Decision Date | 2021-03-07 |