PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)— 510(k) K172423
Substantially EquivalentEdwards Lifescience, LLC
FDA 510(k) clearance K172423 for PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter), Substantially Equivalent on 2018-02-20. Applicant: Edwards Lifescience, LLC. Device class: 2.
Clearance details
- Applicant
- Edwards Lifescience, 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- 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
- K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN
Recalls naming K172423
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K172423.
Data sourced from openFDA. This site is unofficial and independent of the FDA.