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FDA 510(k)

WOLF Thrombectomy System, 6F

K-Number: K210530 · 2021-08-27

ApplicantDevoro Medical, Inc.
Decision Date2021-08-27
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

WOLF Thrombectomy System, 6F 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 2021-08-27 under 510(k) number K210530. 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 System, 6F?

WOLF Thrombectomy System, 6F is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Devoro Medical, Inc.. The 510(k) number is K210530.

When did WOLF Thrombectomy System, 6F receive FDA 510(k) clearance?

WOLF Thrombectomy System, 6F received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210530.

Who is the listed applicant for WOLF Thrombectomy System, 6F?

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 System, 6F?

The FDA product code for WOLF Thrombectomy System, 6F 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, 14FK200101WOLF Thrombectomy V System

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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