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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vacular, Inc.. It received FDA 510(k) clearance on 2016-05-24 under 510(k) 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. The listed applicant is Bard Peripheral Vacular, Inc.. The 510(k) number is K161208.

When did CROSSER CTO Recanalization Catheter receive FDA 510(k) clearance?

CROSSER CTO Recanalization Catheter received FDA 510(k) clearance on 2016-05-24, under 510(k) number K161208.

Who is the listed applicant for CROSSER CTO Recanalization Catheter?

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

What is the FDA product code for CROSSER CTO Recanalization Catheter?

The FDA product code for CROSSER CTO Recanalization Catheter is PDU.

Related Devices (Code: PDU)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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