FDA 510(k)

AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS

K-Number: K093986 · 2010-01-22

Decision Date2010-01-22

Product CodeDTM

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS 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 2010-01-22 under 510(k) number K093986. 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 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS?

AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS is a medical device that received FDA 510(k) clearance on 2010-01-22. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K093986.

When did AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS receive FDA 510(k) clearance?

AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS received FDA 510(k) clearance on 2010-01-22, under 510(k) number K093986.

Who is the listed applicant for AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS?

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 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS?

The FDA product code for AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS is DTM.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sorin Group Italia S.R.L. as applicant

K253671Dual Stage Venous Cannulae K251783Inspire HCR and HCR DUAL cardiotomy reservoirs K253616ProtekDilate Vascular Access Kit K250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

View all 58 devices →

Related Devices (Code: DTM)

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronic K242953KIDS 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 Systems K122760AFFINITY 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.