FDA 510(k)

PENUMBRA EMBOLIZATION COIL SYSTEM

K-Number: K103305 · 2011-01-26

Decision Date2011-01-26

Product CodeHCG

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

PENUMBRA EMBOLIZATION COIL SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2011-01-26 under 510(k) number K103305. The device is classified under product code HCG. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENUMBRA EMBOLIZATION COIL SYSTEM?

PENUMBRA EMBOLIZATION COIL SYSTEM is a medical device that received FDA 510(k) clearance on 2011-01-26. The listed applicant is Penumbra, Inc.. The 510(k) number is K103305.

When did PENUMBRA EMBOLIZATION COIL SYSTEM receive FDA 510(k) clearance?

PENUMBRA EMBOLIZATION COIL SYSTEM received FDA 510(k) clearance on 2011-01-26, under 510(k) number K103305.

Who is the listed applicant for PENUMBRA EMBOLIZATION COIL SYSTEM?

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 EMBOLIZATION COIL SYSTEM?

The FDA product code for PENUMBRA EMBOLIZATION COIL SYSTEM is HCG.

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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.