Crosser iQ CTO Recanalization System
K-Number: K203363 · 2021-08-12
ApplicantC.R. Bard, Inc.
Decision Date2021-08-12
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Crosser iQ CTO Recanalization System is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2021-08-12 under approval number K203363. The device is classified under product code PDU. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Crosser iQ CTO Recanalization System?
Crosser iQ CTO Recanalization System is a medical device that received FDA 510(k) clearance on 2021-08-12. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K203363.
When was Crosser iQ CTO Recanalization System approved by the FDA?
Crosser iQ CTO Recanalization System received FDA 510(k) clearance on 2021-08-12, under approval number K203363.
What company makes Crosser iQ CTO Recanalization System?
Crosser iQ CTO Recanalization System is manufactured by C.R. Bard, Inc..
What is the FDA product code for Crosser iQ CTO Recanalization System?
The FDA product code for Crosser iQ CTO Recanalization System is PDU.
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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.