FDA 510(k)

Crosser iQ CTO Recanalization System

K-Number: K203363 · 2021-08-12

Decision Date2021-08-12

Product CodePDU

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Crosser iQ CTO Recanalization System is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2021-08-12 under 510(k) 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. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K203363.

When did Crosser iQ CTO Recanalization System receive FDA 510(k) clearance?

Crosser iQ CTO Recanalization System received FDA 510(k) clearance on 2021-08-12, under 510(k) number K203363.

Who is the listed applicant for Crosser iQ CTO Recanalization System?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.