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FDA 510(k)

ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS

K-Number: K101431 · 2010-06-25

ApplicantC.R. Bard, Inc.
Decision Date2010-06-25
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS 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 2010-06-25 under 510(k) number K101431. 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 ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS?

ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS is a medical device that received FDA 510(k) clearance on 2010-06-25. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K101431.

When did ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS receive FDA 510(k) clearance?

ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS received FDA 510(k) clearance on 2010-06-25, under 510(k) number K101431.

Who is the listed applicant for ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS?

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 ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS?

The FDA product code for ECLIPSE FILTER SYSTEM-FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS 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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