K231621

Substantially Equivalent

Reprocessed ViewFlex Xtra ICE Catheter (D087031)

Applicant: Stryker Sustainability Solutions
Product code: OWQ
Advisory panel: Cardiovascular
Date received: 2023-06-02
Decision date: 2023-07-25
Decision: Substantially Equivalent
Clearance type: Special
Location: Tempe, AZ, US

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Data sourced from openFDA. This site is unofficial and independent of the FDA.