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FDA 510(k)

SONIXGPS VASCULAR ACCESS NEEDLE KIT

K-Number: K120349 · 2012-04-09

ApplicantUltrasonix Medical Corpation
Decision Date2012-04-09
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SONIXGPS VASCULAR ACCESS NEEDLE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Ultrasonix Medical Corpation. It received FDA 510(k) clearance on 2012-04-09 under 510(k) number K120349. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONIXGPS VASCULAR ACCESS NEEDLE KIT?

SONIXGPS VASCULAR ACCESS NEEDLE KIT is a medical device that received FDA 510(k) clearance on 2012-04-09. The listed applicant is Ultrasonix Medical Corpation. The 510(k) number is K120349.

When did SONIXGPS VASCULAR ACCESS NEEDLE KIT receive FDA 510(k) clearance?

SONIXGPS VASCULAR ACCESS NEEDLE KIT received FDA 510(k) clearance on 2012-04-09, under 510(k) number K120349.

Who is the listed applicant for SONIXGPS VASCULAR ACCESS NEEDLE KIT?

The FDA 510(k) record lists Ultrasonix Medical Corpation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONIXGPS VASCULAR ACCESS NEEDLE KIT?

The FDA product code for SONIXGPS VASCULAR ACCESS NEEDLE KIT is DRE.

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Related Devices (Code: DRE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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