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FDA 510(k)

CAAS A-VALVE

K-Number: K113076 · 2012-01-30

ApplicantPie Medical Imaging BV
Decision Date2012-01-30
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CAAS A-VALVE 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 2012-01-30 under 510(k) number K113076. 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 A-VALVE?

CAAS A-VALVE is a medical device that received FDA 510(k) clearance on 2012-01-30. The listed applicant is Pie Medical Imaging BV. The 510(k) number is K113076.

When did CAAS A-VALVE receive FDA 510(k) clearance?

CAAS A-VALVE received FDA 510(k) clearance on 2012-01-30, under 510(k) number K113076.

Who is the listed applicant for CAAS A-VALVE?

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 A-VALVE?

The FDA product code for CAAS A-VALVE is LLZ.

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Other records listing Pie Medical Imaging BV as applicant

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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Related Devices (Code: LLZ)

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

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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