Data / Medical devices / United Kingdom / Chalice Medical Ltd
Chalice Medical Ltd: FDA-registered device maker in Worksop Nottinghamshire, United Kingdom, 3 510(k) clearances
Chalice Medical Ltd is registered with the FDA (registration 3013267343) in Worksop Nottinghamshire, United Kingdom. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated November 1, 2023. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013267343
- Address
- Manton Wood Enterprise Park, Worksop Nottinghamshire, United Kingdom, S80 2RS
- Owner or operator
- Chalice Medical Limited (10059431)
- Roles
- Manufacturer
- First device listed
- April 9, 2020
- Registered through
- 2026
- Brand names listed
- CMO8 Adult PMP Oxygenator with Tubing Pack, Holder for Standalone CMO8 Adult Oxygenator, Holder for Standalone Paragon Adult, Paediatric & Infant Oxygenator, Paragon Adult Maxi PMP Oxygenator, Paragon Adult Maxi PMP Oxygenator with Tubing Pack
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory Equipment, Cardiopulmonary Bypass | KRI | 1 | Manufacturer | accessdata.fda.gov |
| Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | DWF | 2 | Manufacturer | accessdata.fda.gov |
| Heat-Exchanger, Cardiopulmonary Bypass | DTR | 2 | Manufacturer | accessdata.fda.gov |
| Oxygenator, Cardiopulmonary Bypass | DTZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 1, 2023 | K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | DTZ | Substantially Equivalent | Chalice Medical , Ltd. | accessdata.fda.gov |
| September 18, 2020 | K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | DTZ | Substantially Equivalent | Chalice Medical , Ltd. | accessdata.fda.gov |
| February 28, 2020 | K191246 | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) | DTZ | Substantially Equivalent | Chalice Medical , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Accessory Equipment, Cardiopulmonary Bypass
- All makers of Oxygenator, Cardiopulmonary Bypass
- All makers of Heat-Exchanger, Cardiopulmonary Bypass
- All makers of Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Updated November 1, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.