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FDA 510(k)

CAAS INTRAVASCULAR

K-Number: K123970 · 2013-02-06

ApplicantPie Medical Imaging BV
Decision Date2013-02-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAAS INTRAVASCULAR is the device name listed in this FDA 510(k) record. The listed applicant is Pie Medical Imaging BV. It received FDA 510(k) clearance on 2013-02-06 under 510(k) number K123970. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAAS INTRAVASCULAR?

CAAS INTRAVASCULAR is a medical device that received FDA 510(k) clearance on 2013-02-06. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K123970.

When did CAAS INTRAVASCULAR receive FDA 510(k) clearance?

CAAS INTRAVASCULAR received FDA 510(k) clearance on 2013-02-06, under 510(k) number K123970.

Who is the listed applicant for CAAS INTRAVASCULAR?

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

What is the FDA product code for CAAS INTRAVASCULAR?

The FDA product code for CAAS INTRAVASCULAR is LLZ.

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Other records listing Pie Medical Imaging BV as applicant

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Related Devices (Code: LLZ)

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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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