← FDA Medical Device Classifications

Catheter, Angioplasty, Peripheral, Transluminal

LIT · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1250

Classification

FDA Product Code
LIT
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.1250
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
402
Registered establishments
92

Source

Authoritative
FDA Device Classification database
Machine
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