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FDA 510(k)

CIVASTRING PD-103

K-Number: K082159 · 2008-09-30

ApplicantCivatech Oncology, Inc.
Decision Date2008-09-30
Product CodeKXK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CIVASTRING PD-103 is the device name listed in this FDA 510(k) record. The listed applicant is Civatech Oncology, Inc.. It received FDA 510(k) clearance on 2008-09-30 under 510(k) number K082159. The device is classified under product code KXK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CIVASTRING PD-103?

CIVASTRING PD-103 is a medical device that received FDA 510(k) clearance on 2008-09-30. The listed applicant is Civatech Oncology, Inc.. The 510(k) number is K082159.

When did CIVASTRING PD-103 receive FDA 510(k) clearance?

CIVASTRING PD-103 received FDA 510(k) clearance on 2008-09-30, under 510(k) number K082159.

Who is the listed applicant for CIVASTRING PD-103?

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

What is the FDA product code for CIVASTRING PD-103?

The FDA product code for CIVASTRING PD-103 is KXK.

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Other records listing Civatech Oncology, 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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Related Devices (Code: KXK)

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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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