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FDA 510(k)

G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS

K-Number: K080668 · 2008-07-30

ApplicantC.R. Bard, Inc.
Decision Date2008-07-30
Product CodeDTK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) 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 2008-07-30 under 510(k) number K080668. 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 G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS?

G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS is a medical device that received FDA 510(k) clearance on 2008-07-30. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K080668.

When did G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS receive FDA 510(k) clearance?

G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS received FDA 510(k) clearance on 2008-07-30, under 510(k) number K080668.

Who is the listed applicant for G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) 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 G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS?

The FDA product code for G2 EXPRESS FILTER SYSTEM-FEMORAL (RF400F) AND JUGULAR/SUBCLAVIAN (RF400J) DELIVERY KITS is DTK.

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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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