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FDA 510(k)

WOLF Thrombectomy V System

K-Number: K200101 · 2020-04-27

ApplicantDevoro Medical, Inc.
Decision Date2020-04-27
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WOLF Thrombectomy V System is the device name listed in this FDA 510(k) record. The listed applicant is Devoro Medical, Inc.. It received FDA 510(k) clearance on 2020-04-27 under 510(k) number K200101. 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 V System?

WOLF Thrombectomy V System is a medical device that received FDA 510(k) clearance on 2020-04-27. The listed applicant is Devoro Medical, Inc.. The 510(k) number is K200101.

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

WOLF Thrombectomy V System received FDA 510(k) clearance on 2020-04-27, under 510(k) number K200101.

Who is the listed applicant for WOLF Thrombectomy V System?

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

What is the FDA product code for WOLF Thrombectomy V System?

The FDA product code for WOLF Thrombectomy V System is QEW.

Other records listing Devoro Medical, Inc. as applicant

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.

K241207SmartClaw™ Thrombectomy Catheter, 20 mm (FD0660-01), SmartClaw™ Thrombectomy Catheter, 32 mm (FD0660-02)K221391WOLF Thrombectomy™ SmartClaw CatheterK210911WOLF Thrombectomy System, 14FK210530WOLF Thrombectomy System, 6F

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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