Bunkerhill Contrast AVC
K-Number: K260167 · 2026-03-06
ApplicantBunkerHill Health
Decision Date2026-03-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Bunkerhill Contrast AVC is a medical device manufactured by BunkerHill Health. It received FDA 510(k) clearance on 2026-03-06 under approval number K260167. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Bunkerhill Contrast AVC?
Bunkerhill Contrast AVC is a medical device that received FDA 510(k) clearance on 2026-03-06. It is manufactured by BunkerHill Health. The 510(k) number is K260167.
When was Bunkerhill Contrast AVC approved by the FDA?
Bunkerhill Contrast AVC received FDA 510(k) clearance on 2026-03-06, under approval number K260167.
What company makes Bunkerhill Contrast AVC?
Bunkerhill Contrast AVC is manufactured by BunkerHill Health.
What is the FDA product code for Bunkerhill Contrast AVC?
The FDA product code for Bunkerhill Contrast AVC is JAK.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.