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FDA 510(k)

PENUMBRA CATHERER 025

K-Number: K100826 · 2010-07-13

ApplicantPenumbra, Inc.
Decision Date2010-07-13
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PENUMBRA CATHERER 025 is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2010-07-13 under 510(k) number K100826. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENUMBRA CATHERER 025?

PENUMBRA CATHERER 025 is a medical device that received FDA 510(k) clearance on 2010-07-13. The listed applicant is Penumbra, Inc.. The 510(k) number is K100826.

When did PENUMBRA CATHERER 025 receive FDA 510(k) clearance?

PENUMBRA CATHERER 025 received FDA 510(k) clearance on 2010-07-13, under 510(k) number K100826.

Who is the listed applicant for PENUMBRA CATHERER 025?

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

What is the FDA product code for PENUMBRA CATHERER 025?

The FDA product code for PENUMBRA CATHERER 025 is DQY.

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Other records listing Penumbra, Inc. as applicant

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Related Devices (Code: DQY)

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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