510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132905Substantially Equivalent

200 Micron Blood Component Filter and Syringe Adapter

Arteriocyte Medical Systems, Inc., Hopkinton MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132905 is the FDA 510(k) clearance record for 200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTER, a class II device, cleared for Arteriocyte Medical Systems, Inc. on under FDA product code BRZ (Set, Blood Transfusion). FDA records list one 510(k) clearance for Arteriocyte Medical Systems, Inc. As of , FDA records show no recalls naming K132905.

Clearance record

Decision date
Received
(18 days to decision)
Product code
BRZ Set, Blood Transfusion
Regulation
21 CFR 880.5440
Device class
Class II
Review panel
General Hospital
Applicant
Arteriocyte Medical Systems, Inc. 45 S. St., Hopkinton MA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code BRZ

Trailing 12 months

FDA records hold no clearances under product code BRZ in the trailing twelve months.

FDA records show no clearances under product code BRZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code BRZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260