510(k) K053609 ยท DQE Catheter, Oximeter, Fiber-Optic
PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR
| Applicant | Edwards Lifesciences, LLC, Irvine CA, US |
| Decision | Substantially Equivalent, Feb 28, 2006 |
| Received | Dec 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053609
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 9, 2021 | Edwards Lifesciences, LLC Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI Terminated |
DQE | None listed |
| Jul 9, 2021 | Edwards Lifesciences, LLC Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 15 cm, Number of Lumens 3, Recommended Guidewire Size 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: Terminated |
DQE | None listed |
| Jul 9, 2021 | Edwards Lifesciences, LLC Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of Lumens 3, Exterior Diameter 5.5F, Rx Only, Sterile EO, UDI: (01)00690103197495
*NOT DISTRIBUTED WITHIN THE US Terminated |
DQE | None listed |
| Jul 9, 2021 | Edwards Lifesciences, LLC Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm), Usable Length 9 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, Terminated |
DQE | None listed |
| Jul 9, 2021 | Edwards Lifesciences, LLC Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable Length 8 cm, Number of Lumens: 3, Recommended Guidewire Size: GW: 0.025" (0.64 mm), Rx Only, Sterile EO, UDI: (01 Terminated |
DQE | None listed |
| Jul 9, 2021 | Edwards Lifesciences, LLC Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable Length 15 cm, Number of Lumens: 3, Rx Only, Sterile EO, UDI: (01)00690103197501
*NOT DISTRIBUTED WITHIN THE US Terminated |
DQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.