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FDA 510(k)

SILK ROAD ACCESS CATHETER

K-Number: K130649 · 2013-11-01

ApplicantSilk Road Medical, Inc.
Decision Date2013-11-01
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SILK ROAD ACCESS CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Silk Road Medical, Inc.. It received FDA 510(k) clearance on 2013-11-01 under 510(k) number K130649. 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 SILK ROAD ACCESS CATHETER?

SILK ROAD ACCESS CATHETER is a medical device that received FDA 510(k) clearance on 2013-11-01. The listed applicant is Silk Road Medical, Inc.. The 510(k) number is K130649.

When did SILK ROAD ACCESS CATHETER receive FDA 510(k) clearance?

SILK ROAD ACCESS CATHETER received FDA 510(k) clearance on 2013-11-01, under 510(k) number K130649.

Who is the listed applicant for SILK ROAD ACCESS CATHETER?

The FDA 510(k) record lists Silk Road Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SILK ROAD ACCESS CATHETER?

The FDA product code for SILK ROAD ACCESS CATHETER is DQY.

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Other records listing Silk Road Medical, Inc. as applicant

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Related Devices (Code: DQY)

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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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