510(k) K131666 ยท DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
ARTERIAL HLS CANNULA 13 FR NON-COATED, WITH BIOLINE COATING AND WITH SOFTLINE COATING
| Applicant | Maquet Cardiopulmonary, AG, Hechingen, DE |
| Decision | Substantially Equivalent, Jul 5, 2013 |
| Received | Jun 7, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K131666
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), Guidewire 100 cm, Model Numbers: 701053068 (USA), 701047384 (OUS); Open, Classified |
DWF | None listed |
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), Guidewire 150 cm, Model Numbers: 701053069 (USA), 701047385 (OUS); Open, Classified |
DWF | None listed |
| Sep 11, 2026 | Maquet Cardiopulmonary Gmbh Percutaneous Insertion Kit (PIK), dilator set L, Model Numbers: 701054427 (USA), 701054427 (OUS); Open, Classified |
DWF | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.