← FDA Medical Device Classifications

System, Catheter Or Guidewire, Steerable (Magnetic)

NDQ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1290

Classification

FDA Product Code

NDQ

Device class

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

Regulation

21 CFR 870.1290

Review panel

NE

Medical specialty

Cardiovascular

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

N

Market data

Cleared 510(k) submissions

2

Registered establishments

1

Source

Authoritative

FDA Device Classification database

Machine

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