FDA 510(k)

CROSSER RECANALIZATION SYSTEM

K-Number: K112308 · 2011-08-17

Decision Date2011-08-17

Product CodePDU

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CROSSER 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 2011-08-17 under 510(k) number K112308. 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 RECANALIZATION SYSTEM?

CROSSER RECANALIZATION SYSTEM is a medical device that received FDA 510(k) clearance on 2011-08-17. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K112308.

When did CROSSER RECANALIZATION SYSTEM receive FDA 510(k) clearance?

CROSSER RECANALIZATION SYSTEM received FDA 510(k) clearance on 2011-08-17, under 510(k) number K112308.

Who is the listed applicant for CROSSER 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 RECANALIZATION SYSTEM?

The FDA product code for CROSSER 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.