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

Oxygenator, Long Term Support Greater Than 6 Hours

21 CFR 870.4100 / Cardiovascular
FDA source (opens on fda.gov)

BYS is the FDA product code for Oxygenator, Long Term Support Greater Than 6 Hours, a class II device type, regulated under 21 CFR 870.4100. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
BYS
Device name
Oxygenator, Long Term Support Greater Than 6 Hours
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
3
Ingested recalls
2

Clearances, product code BYS

By decision year
3 clearances under product code BYS with a decision year between 1977 and 2023, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code BYS by decision year
YearClearances
19771
20201
20231

Applicants with the most clearances

Product code BYS
Applicants holding the most 510(k) clearances under product code BYS
ApplicantClearances
Mc3 Incorporated1
MC3, Inc.1
William Harvey Life Products Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code