← FDA Medical Device Classifications

Clip, Implantable, For Coronary Artery Bypass Graft (Cabg)

NCA · Class II — Moderate Risk (510(k) clearance required) · General, Plastic Surgery · 21 CFR 878.4300

Classification

FDA Product Code
NCA
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 878.4300
Review panel
SU
Medical specialty
General, Plastic Surgery
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Market data

Cleared 510(k) submissions
3
Registered establishments
0

Source

Authoritative
FDA Device Classification database
Machine
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