Intera Refill Kit
K-Number: K213823 · 2022-03-16
ApplicantIntera Oncology, Inc.
Decision Date2022-03-16
Product CodePTI
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Intera Refill Kit is a medical device manufactured by Intera Oncology, Inc.. It received FDA 510(k) clearance on 2022-03-16 under approval number K213823. The device is classified under product code PTI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Intera Refill Kit?
Intera Refill Kit is a medical device that received FDA 510(k) clearance on 2022-03-16. It is manufactured by Intera Oncology, Inc.. The 510(k) number is K213823.
When was Intera Refill Kit approved by the FDA?
Intera Refill Kit received FDA 510(k) clearance on 2022-03-16, under approval number K213823.
What company makes Intera Refill Kit?
Intera Refill Kit is manufactured by Intera Oncology, Inc..
What is the FDA product code for Intera Refill Kit?
The FDA product code for Intera Refill Kit is PTI.
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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.