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FDA 510(k)

PENUMBRA SYSTEM MAX

K-Number: K113163 · 2011-11-23

ApplicantPenumbra, Inc.
Decision Date2011-11-23
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PENUMBRA SYSTEM MAX is the device name listed in this FDA 510(k) record. The listed applicant is Penumbra, Inc.. It received FDA 510(k) clearance on 2011-11-23 under 510(k) number K113163. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENUMBRA SYSTEM MAX?

PENUMBRA SYSTEM MAX is a medical device that received FDA 510(k) clearance on 2011-11-23. The listed applicant is Penumbra, Inc.. The 510(k) number is K113163.

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

PENUMBRA SYSTEM MAX received FDA 510(k) clearance on 2011-11-23, under 510(k) number K113163.

Who is the listed applicant for PENUMBRA SYSTEM MAX?

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 SYSTEM MAX?

The FDA product code for PENUMBRA SYSTEM MAX is NRY.

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Other records listing Penumbra, Inc. as applicant

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Related Devices (Code: NRY)

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.

K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc.K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.

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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