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FDA 510(k)

NEURON SELECT CATHETER SIZE 070

K-Number: K083125 · 2008-11-21

ApplicantPenumbra, Inc.
Decision Date2008-11-21
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEURON SELECT CATHETER SIZE 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 2008-11-21 under 510(k) number K083125. 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 SELECT CATHETER SIZE 070?

NEURON SELECT CATHETER SIZE 070 is a medical device that received FDA 510(k) clearance on 2008-11-21. The listed applicant is Penumbra, Inc.. The 510(k) number is K083125.

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

NEURON SELECT CATHETER SIZE 070 received FDA 510(k) clearance on 2008-11-21, under 510(k) number K083125.

Who is the listed applicant for NEURON SELECT CATHETER SIZE 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 SELECT CATHETER SIZE 070?

The FDA product code for NEURON SELECT CATHETER SIZE 070 is DQY.

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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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