510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894657Substantially Equivalent

Polystan Heart-Lung Machine System

Polystan C/O Vitalcor, Inc., Denmark, DK / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K894657 is the FDA 510(k) clearance record for POLYSTAN HEART-LUNG MACHINE SYSTEM, a class II device, cleared for Polystan C/O Vitalcor, Inc. on under FDA product code DJQ (Test Reagents For Phenothiazine). FDA records list 8 510(k) clearances for Polystan C/O Vitalcor, Inc., from to . As of , FDA records show no recalls naming K894657.

Clearance record

Decision date
Received
(247 days to decision)
Product code
DJQ Test Reagents For Phenothiazine
Regulation
21 CFR 862.3670
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Polystan C/O Vitalcor, Inc. 8, Walgerholm, Denmark, DK
Third party review
No

Clearances, product code DJQ

Trailing 12 months

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

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