Electronic Instructions for Use
Electronic Instructions for Use are provided in standard adobe acrobat pdf format.
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Disclaimer & Regulatory Information
Ankyras is manufactured by Mentice Spain S.L.
ANKYRAS is intended to be used by physicians trained in medical procedures involving percutaneous and intravascular interventions.
Ankyras is 510(k) cleared by FDA.
Mentice Spain SL: Mentice Spain SL has obtained the ISO 13485 certification with number MD 784027
Ankyras certifications: The Ankyras product complies with the Medical Device Regulation (EU CE Mark, MDR 784032) and the UK Conformity Assessed (UKCA 784033)
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