510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K943803Substantially Equivalent

Jostra Hl-20 Integrated Perfusion System

Janus Biomedical, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K943803 is the FDA 510(k) clearance record for JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM, a class II device, cleared for Janus Biomedical, Inc. on under FDA product code DTQ (Console, Heart-Lung Machine, Cardiopulmonary Bypass). FDA records list 2 510(k) clearances for Janus Biomedical, Inc., from to . As of , FDA records show 5 recalls naming K943803.

Clearance record

Decision date
Received
(544 days to decision)
Product code
DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
Regulation
21 CFR 870.4220
Device class
Class II
Review panel
Cardiovascular
Applicant
Janus Biomedical, Inc. 2525 Hartford Rd., Austin TX
510(k) summary
Summary
Third party review
No

Clearances, product code DTQ

Trailing 12 months

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

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