CROSSER CTO Recanalization Catheter
K-Number: K161208 · 2016-05-24
ApplicantBard Peripheral Vacular, Inc.
Decision Date2016-05-24
Product CodePDU
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
CROSSER CTO Recanalization Catheter is a medical device manufactured by Bard Peripheral Vacular, Inc.. It received FDA 510(k) clearance on 2016-05-24 under approval number K161208. 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 CTO Recanalization Catheter?
CROSSER CTO Recanalization Catheter is a medical device that received FDA 510(k) clearance on 2016-05-24. It is manufactured by Bard Peripheral Vacular, Inc.. The 510(k) number is K161208.
When was CROSSER CTO Recanalization Catheter approved by the FDA?
CROSSER CTO Recanalization Catheter received FDA 510(k) clearance on 2016-05-24, under approval number K161208.
What company makes CROSSER CTO Recanalization Catheter?
CROSSER CTO Recanalization Catheter is manufactured by Bard Peripheral Vacular, Inc..
What is the FDA product code for CROSSER CTO Recanalization Catheter?
The FDA product code for CROSSER CTO Recanalization Catheter 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.