AF 840 PH.I.S.I.O. ARTERIAL FILTER— 510(k) K093601

Name: FDA 510(k) clearance K093601
Creator: U.S. Food and Drug Administration
Published: 2009-12-18

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K093601 for AF 840 PH.I.S.I.O. ARTERIAL FILTER, Substantially Equivalent on 2009-12-18. Applicant: Sorin Group Italia S.R.L.. Device class: 2.

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2009-11-20
Decision date: 2009-12-18
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTM

view all

K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter2026-01-16
K242953 — KIDS Arterial Filters2024-12-20
K242092 — MICRO Arterial Filters2024-11-18
K231362 — OCS Heart Leukocyte Depleting Filter2023-10-31
K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE2013-03-19

More clearances from Sorin Group Italia S.R.L.

view all

K253671 — Dual Stage Venous Cannulae2026-01-30
K251783 — Inspire HCR and HCR DUAL cardiotomy reservoirs2025-12-22
K253616 — ProtekDilate Vascular Access Kit2025-12-19
K250610 — Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)2025-06-27
K250150 — VANGUARD Blood cardioplegia Systems (3 models)2025-05-30

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