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FDA 510(k)

AF 840 PH.I.S.I.O. ARTERIAL FILTER

K-Number: K093601 · 2009-12-18

ApplicantSorin Group Italia S.R.L.
Decision Date2009-12-18
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AF 840 PH.I.S.I.O. ARTERIAL FILTER is the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2009-12-18 under 510(k) number K093601. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AF 840 PH.I.S.I.O. ARTERIAL FILTER?

AF 840 PH.I.S.I.O. ARTERIAL FILTER is a medical device that received FDA 510(k) clearance on 2009-12-18. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K093601.

When did AF 840 PH.I.S.I.O. ARTERIAL FILTER receive FDA 510(k) clearance?

AF 840 PH.I.S.I.O. ARTERIAL FILTER received FDA 510(k) clearance on 2009-12-18, under 510(k) number K093601.

Who is the listed applicant for AF 840 PH.I.S.I.O. ARTERIAL FILTER?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AF 840 PH.I.S.I.O. ARTERIAL FILTER?

The FDA product code for AF 840 PH.I.S.I.O. ARTERIAL FILTER is DTM.

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Related Devices (Code: DTM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K242092MICRO Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.K123351AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACEMedtronic Perfusion SystemsK122760AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACEMedtronic, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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