PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR— 510(k) K053609
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K053609 for PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR, Substantially Equivalent on 2006-02-28. Applicant: Edwards Lifesciences, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifesciences, LLC
- Product code
- Code DQE
- Device class
- Class 2
- Regulation
- 21 CFR 870.1230
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Irvine, CA, US
Recent devices under product code DQE
view all- K172423 — PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)
- K160645 — PreSep Oligon Oximetry Catheter
- K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER
- K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)
- K091268 — HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS
More clearances from Edwards Lifesciences, LLC
view allRecalls naming K053609
K-number listed on FDA's recall record- Z-2278-2021 — 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: (01)00690103197563
- Z-2279-2021 — 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: (01)00690103197532
- Z-2280-2021 — 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
- Z-2281-2021 — 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, UDI: (01)00690103197525 *NOT DISTRIBUTED WITHIN THE US
- Z-2282-2021 — 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)00690103197556
- Z-2283-2021 — 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
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K053609.
Data sourced from openFDA. This site is unofficial and independent of the FDA.