← FDA Medical Device Classifications

Cannula, A-V Shunt

FIQ · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5540

Classification

FDA Product Code
FIQ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 876.5540
Review panel
GU
Medical specialty
Gastroenterology, Urology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Market data

Cleared 510(k) submissions
23
Registered establishments
6

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown