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FDA 510(k)

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519

K-Number: K093406 · 2010-03-25

ApplicantAngioDynamics, Inc.
Decision Date2010-03-25
Product CodeLJS
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 is the device name listed in this FDA 510(k) record. The listed applicant is AngioDynamics, Inc.. It received FDA 510(k) clearance on 2010-03-25 under 510(k) number K093406. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519?

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 is a medical device that received FDA 510(k) clearance on 2010-03-25. The listed applicant is AngioDynamics, Inc.. The 510(k) number is K093406.

When did MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 receive FDA 510(k) clearance?

MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 received FDA 510(k) clearance on 2010-03-25, under 510(k) number K093406.

Who is the listed applicant for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519?

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

What is the FDA product code for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519?

The FDA product code for MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 is LJS.

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Related Devices (Code: LJS)

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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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