The following data is part of a premarket notification filed by Chalice Medical Ltd with the FDA for Paragon Adult Maxi Pmp Oxygenator (model: Xcmop405pmp).
| Device ID | K191246 |
| 510k Number | K191246 |
| Device Name: | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) |
| Classification | Oxygenator, Cardiopulmonary Bypass |
| Applicant | Chalice Medical Ltd Manton Wood Enterprise Park, Worksop, GB S80 2rs |
| Contact | Carol Middleton |
| Correspondent | Carol Middleton Chalice Medical Ltd Manton Wood Enterprise Park, Worksop, GB S80 2rs |
| Product Code | DTZ |
| CFR Regulation Number | 870.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-09 |
| Decision Date | 2020-02-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060491617915 | K191246 | 000 |