← FDA Medical Device Classifications

Pump, Blood, Cardiopulmonary Bypass, Roller Type

DWB · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4370

Classification

FDA Product Code

DWB

Device class

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

Regulation

21 CFR 870.4370

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

21

Registered establishments

3

Source

Authoritative

FDA Device Classification database

Machine

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