PRESEP OLIGON OXIMETRY CATHETERS— 510(k) K060093
Substantially EquivalentEdwards Lifesciences, LLC
FDA 510(k) clearance K060093 for PRESEP OLIGON OXIMETRY CATHETERS, Substantially Equivalent on 2006-04-28. 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
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