Chalice Medical Ltd
Worksop Nottinghamshire, GB
Chalice Medical Ltd appears in FDA device records in Worksop Nottinghamshire, GB. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Chalice Medical Ltd between 2020 and 2023. The busiest year on record is 2020, with 2. The most recent is 2023, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2020 | 2 |
| 2023 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K231414 | CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) | DTZ | Substantially Equivalent | |
| K201642 | Paragon Adult Maxi PMP Oxygenator with Tubing Pack | DTZ | Substantially Equivalent | |
| K191246 | Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) | DTZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3013267343 | 3013267343 | Chalice Medical Ltd | Manton Wood Enterprise Park, Worksop Nottinghamshire S80 2RS GB | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain