510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K890113Substantially Equivalent

The Cdi(r) System 400

Cardiovascular Devices, Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K890113 is the FDA 510(k) clearance record for THE CDI(R) SYSTEM 400, a class I device, cleared for Cardiovascular Devices, Inc. on under FDA product code DJY (Ion-Exchange Chromatography). FDA records list 8 510(k) clearances for Cardiovascular Devices, Inc., from to . As of , FDA records show no recalls naming K890113.

Clearance record

Decision date
Received
(132 days to decision)
Product code
DJY Ion-Exchange Chromatography
Regulation
21 CFR 862.2230
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Cardiovascular Devices, Inc. 2801 Barranca, Irvine CA
Third party review
No

Clearances, product code DJY

Trailing 12 months

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

FDA records show no clearances under product code DJY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DJY, 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