Panels › Cardiovascular › Product code DQE · Class 2
Catheter, Oximeter, Fiber-Optic
Regulation 870.1230
0510(k)s in 12 months (19 all time)
0recalls in 12 months (14 all time)
13recalls that name a 510(k)
Top companies in DQE
| Company | 510(k)s | Recalls |
|---|---|---|
| Edwards Lifesciences, LLC | 4 | 7 |
| Icu Medical, Inc. | 1 | 7 |
| Hospira, Inc. | 5 | 0 |
| Baxter Healthcare Corp | 3 | 0 |
| Oximetrix, Inc. | 3 | 0 |
| Criticare Systems, Inc. | 1 | 0 |
| Edwards Lifescience, LLC | 1 | 0 |
| Marquette Electronics, Inc. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K053609 |
| 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 | K053609 |
| 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 | K053609 |
| 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 | K053609 |
| 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 | K053609 |
| 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 | K053609 |
| Jul 10, 2020 | Edwards Lifesciences, LLC Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/ (01)00690103197181 Terminated |
DQE | K172423 |
| Jan 2, 2020 | ICU Medical, Inc. Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 504 Terminated |
DQE | K061585 |
| Jan 2, 2020 | ICU Medical, Inc. Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 414 Terminated |
DQE | K091268 |
| Jan 2, 2020 | ICU Medical, Inc. Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 414 Terminated |
DQE | K091268 |
| Jan 2, 2020 | ICU Medical, Inc. Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 414 Terminated |
DQE | K091268 |
| Jan 2, 2020 | ICU Medical, Inc. Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 414 Terminated |
DQE | K091268 |
| Jan 2, 2020 | ICU Medical, Inc. Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 414 Terminated |
DQE | K091268 |
| Jan 2, 2020 | ICU Medical, Inc. Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. LOT Number Terminated |
DQE | None listed |
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