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FDA 510(k)

DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY

K-Number: K093822 · 2010-01-28

ApplicantShepherd Scientific, Inc.
Decision Date2010-01-28
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY is the device name listed in this FDA 510(k) record. The listed applicant is Shepherd Scientific, Inc.. It received FDA 510(k) clearance on 2010-01-28 under 510(k) number K093822. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY?

DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY is a medical device that received FDA 510(k) clearance on 2010-01-28. The listed applicant is Shepherd Scientific, Inc.. The 510(k) number is K093822.

When did DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY receive FDA 510(k) clearance?

DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY received FDA 510(k) clearance on 2010-01-28, under 510(k) number K093822.

Who is the listed applicant for DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY?

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

What is the FDA product code for DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY?

The FDA product code for DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY is DQX.

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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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