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FDA 510(k)

NEURON DELIVERY CATHETER 070

K-Number: K082290 · 2008-10-31

ApplicantPenumbra, Inc.
Decision Date2008-10-31
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEURON DELIVERY CATHETER 070 is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2008-10-31 under 510(k) number K082290. 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 NEURON DELIVERY CATHETER 070?

NEURON DELIVERY CATHETER 070 is a medical device that received FDA 510(k) clearance on 2008-10-31. The listed applicant is Penumbra, Inc.. The 510(k) number is K082290.

When did NEURON DELIVERY CATHETER 070 receive FDA 510(k) clearance?

NEURON DELIVERY CATHETER 070 received FDA 510(k) clearance on 2008-10-31, under 510(k) number K082290.

Who is the listed applicant for NEURON DELIVERY CATHETER 070?

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 NEURON DELIVERY CATHETER 070?

The FDA product code for NEURON DELIVERY CATHETER 070 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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