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FDA 510(k)

WOLF Thrombectomy Device

K-Number: K182835 · 2019-03-27

Applicant880 Medical, LLC
Decision Date2019-03-27
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WOLF Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is 880 Medical, LLC. It received FDA 510(k) clearance on 2019-03-27 under 510(k) number K182835. 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 WOLF Thrombectomy Device?

WOLF Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2019-03-27. The listed applicant is 880 Medical, LLC. The 510(k) number is K182835.

When did WOLF Thrombectomy Device receive FDA 510(k) clearance?

WOLF Thrombectomy Device received FDA 510(k) clearance on 2019-03-27, under 510(k) number K182835.

Who is the listed applicant for WOLF Thrombectomy Device?

The FDA 510(k) record lists 880 Medical, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for WOLF Thrombectomy Device?

The FDA product code for WOLF Thrombectomy Device is QEW.

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.

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.K251949INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKPenumbra, Inc.K253730RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.K251207Sangria™ Thrombectomy SystemAvantec Vascular Corporation

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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