← FDA Medical Device Classifications

Gauge, Pressure, Coronary, Cardiopulmonary Bypass

DXS · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4310

Classification

FDA Product Code

DXS

Device class

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

Regulation

21 CFR 870.4310

Review panel

CV

Medical specialty

Cardiovascular

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

13

Registered establishments

4

Source

Authoritative

FDA Device Classification database

Machine

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