DWC · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.4250
Classification
FDA Product Code
DWC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.4250
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
Definition
If the device is reusable, validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission (82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).