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FDA 510(k)

MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT

K-Number: K112497 · 2011-10-24

ApplicantC.R. Bard, Inc.
Decision Date2011-10-24
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT 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 2011-10-24 under 510(k) number K112497. The device is classified under product code DTK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT?

MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT is a medical device that received FDA 510(k) clearance on 2011-10-24. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K112497.

When did MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT receive FDA 510(k) clearance?

MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT received FDA 510(k) clearance on 2011-10-24, under 510(k) number K112497.

Who is the listed applicant for MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT?

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 MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT?

The FDA product code for MERIDIAN FILTER SYSTEM - FEMORAL DELIVERY KIT is DTK.

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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.

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