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FDA 510(k)

SIDEKICK and USHER Support Catheters

K-Number: K161986 · 2016-08-04

ApplicantBard Peripheral Vascular, Inc.
Decision Date2016-08-04
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIDEKICK and USHER Support Catheters is the device name listed in this FDA 510(k) record. The listed applicant is Bard Peripheral Vascular, Inc.. It received FDA 510(k) clearance on 2016-08-04 under 510(k) number K161986. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIDEKICK and USHER Support Catheters?

SIDEKICK and USHER Support Catheters is a medical device that received FDA 510(k) clearance on 2016-08-04. The listed applicant is Bard Peripheral Vascular, Inc.. The 510(k) number is K161986.

When did SIDEKICK and USHER Support Catheters receive FDA 510(k) clearance?

SIDEKICK and USHER Support Catheters received FDA 510(k) clearance on 2016-08-04, under 510(k) number K161986.

Who is the listed applicant for SIDEKICK and USHER Support Catheters?

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

What is the FDA product code for SIDEKICK and USHER Support Catheters?

The FDA product code for SIDEKICK and USHER Support Catheters is DQY.

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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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