510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K093986Substantially Equivalent

Af 620 Ph.i.s.i.o., Af 640 Ph.i.s.i.o. Arterial Filters

Corcym Inc., Waltham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K093986 is the FDA 510(k) clearance record for AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS, a class II device, cleared for Sorin Group Italia S.R.L. on under FDA product code DTM (Filter, Blood, Cardiopulmonary Bypass, Arterial Line). FDA records list 64 510(k) clearances for Corcym Inc., from to . As of , FDA records show no recalls naming K093986.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation
21 CFR 870.4260
Device class
Class II
Review panel
Cardiovascular
Applicant
Sorin Group Italia S.R.L. 195 W. St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DTM

Trailing 12 months
1 clearance under product code DTM in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DTM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260