OFH · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.1650
Classification
FDA Product Code
OFH
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.1650
Review panel
CV
Medical specialty
Cardiovascular
Submission type
7
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
Definition
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.