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FDA 510(k)

NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F

K-Number: K070970 · 2007-08-17

ApplicantPenumbra, Inc.
Decision Date2007-08-17
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2007-08-17 under 510(k) number K070970. 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 SUPPORT CATHETER SYSTEM, MODEL 5F/6F?

NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F is a medical device that received FDA 510(k) clearance on 2007-08-17. The listed applicant is Penumbra, Inc.. The 510(k) number is K070970.

When did NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F receive FDA 510(k) clearance?

NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F received FDA 510(k) clearance on 2007-08-17, under 510(k) number K070970.

Who is the listed applicant for NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F?

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 SUPPORT CATHETER SYSTEM, MODEL 5F/6F?

The FDA product code for NEURON SUPPORT CATHETER SYSTEM, MODEL 5F/6F is DQY.

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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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