NLI · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1200
Classification
FDA Product Code
NLI
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.1200
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
Reprocessing validation data for this device type must be included in a 510(k) submission. (70 FR 56911, available at https://www.govinfo.gov/content/pkg/FR-2005-09-29/pdf/05-19510.pdf).