PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)— 510(k) K110167

Substantially Equivalent

Edwards Lifesciences, LLC

FDA 510(k) clearance K110167 for PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN), Substantially Equivalent on 2011-02-18. Applicant: Edwards Lifesciences, LLC.

Clearance details

Applicant: Edwards Lifesciences, LLC
Product code: Code DQE
Advisory panel: Cardiovascular
Date received: 2011-01-20
Decision date: 2011-02-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Irvine, CA, US

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