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FDA 510(k)

ASTRA

K-Number: K111694 · 2011-09-15

ApplicantCandelis, Inc.
Decision Date2011-09-15
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASTRA is the device name listed in this FDA 510(k) record. The listed applicant is Candelis, Inc.. It received FDA 510(k) clearance on 2011-09-15 under 510(k) number K111694. 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 ASTRA?

ASTRA is a medical device that received FDA 510(k) clearance on 2011-09-15. The listed applicant is Candelis, Inc.. The 510(k) number is K111694.

When did ASTRA receive FDA 510(k) clearance?

ASTRA received FDA 510(k) clearance on 2011-09-15, under 510(k) number K111694.

Who is the listed applicant for ASTRA?

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

What is the FDA product code for ASTRA?

The FDA product code for ASTRA is LLZ.

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Other records listing Candelis, Inc. 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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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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