The following data is part of a premarket notification filed by Chalice Medical Ltd with the FDA for Paragon Adult Maxi Pmp Oxygenator With Tubing Pack.
| Device ID | K201642 |
| 510k Number | K201642 |
| Device Name: | Paragon Adult Maxi PMP Oxygenator With Tubing Pack |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Chalice Medical Ltd Manton Wood Enterprise Park Worksop, GB S80 2rs |
| Contact | Stephen Horan |
| Correspondent | Stephen Horan Chalice Medical Ltd Manton Wood Enterprise Park Worksop, GB S80 2rs |
| Product Code | DTZ |
| Subsequent Product Code | DTR |
| Subsequent Product Code | DWF |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-17 |
| Decision Date | 2020-09-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15060491614126 | K201642 | 000 |