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FDA 510(k)

PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM

K-Number: K121917 · 2012-09-19

ApplicantPenumbra, Inc.
Decision Date2012-09-19
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PENUMBRA EMBOLECTOMY ASPIRATION 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 2012-09-19 under 510(k) number K121917. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM?

PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM is a medical device that received FDA 510(k) clearance on 2012-09-19. The listed applicant is Penumbra, Inc.. The 510(k) number is K121917.

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

PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM received FDA 510(k) clearance on 2012-09-19, under 510(k) number K121917.

Who is the listed applicant for PENUMBRA EMBOLECTOMY ASPIRATION 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 EMBOLECTOMY ASPIRATION SYSTEM?

The FDA product code for PENUMBRA EMBOLECTOMY ASPIRATION SYSTEM is QEW.

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Other records listing Penumbra, Inc. as applicant

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Related Devices (Code: QEW)

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.

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular EngineeringK262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ Thrombectomy SystemJupiter EndovascularK260599INDIGO® Aspiration System – INDIGO LinkPenumbra, Inc.K260028CLEANER™ Vac Thrombectomy System, CLEANER™ Vac Aspiration Catheter with Handpiece, CLEANER™ Vac Aspiration CanisterArgon Medical Devices, 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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