510(k) K053025 ยท DWE Tubing, Pump, Cardiopulmonary Bypass
JOSTRA HLM TUBING SET
| Applicant | Maquet Cardiopulmonary, AG, Fairfield IA, US |
| Decision | Substantially Equivalent, Nov 10, 2005 |
| Received | Oct 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053025
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2017 | Maquet Hemofiltration Standard Pack including BC 60 Plus-T 8036. Part Number: 701066990.
Used in extracorporeal circulation during cardiopulmonary bypass procedures lasting 6 hours or less. Terminated |
DWE | None listed |
| Sep 12, 2010 | Maquet Inc. Maquet HLM Tubing Pack; Bioline Coating Terminated |
DWE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.