510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830634Substantially Equivalent

Cardiotomy Filter

Texas Medical Products, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830634 is the FDA 510(k) clearance record for CARDIOTOMY FILTER, a class II device, cleared for Texas Medical Products, Inc. on under FDA product code JOD (Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass). FDA records list 30 510(k) clearances for Texas Medical Products, Inc., from to . As of , FDA records show no recalls naming K830634.

Clearance record

Decision date
Received
(121 days to decision)
Product code
JOD Filter, Blood, Cardiotomy Suction Line, Cardiopulmonary Bypass
Regulation
21 CFR 870.4270
Device class
Class II
Review panel
Cardiovascular
Applicant
Texas Medical Products, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JOD

Trailing 12 months

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

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