← FDA Medical Device Classifications

Oxygenator, Long Term Support Greater Than 6 Hours

BYS · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4100

Classification

FDA Product Code

BYS

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 870.4100

Review panel

CV

Medical specialty

Cardiovascular

Submission type

1

GMP exempt

N

Life sustaining

Y

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

3

Registered establishments

7

Source

Authoritative

FDA Device Classification database

Machine

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