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FDA 510(k)

V2K Rinspiration System

K-Number: K172716 · 2018-01-26

ApplicantV2k Medical, Inc.
Decision Date2018-01-26
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

V2K Rinspiration System is the device name listed in this FDA 510(k) record. The listed applicant is V2k Medical, Inc.. It received FDA 510(k) clearance on 2018-01-26 under 510(k) number K172716. 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 V2K Rinspiration System?

V2K Rinspiration System is a medical device that received FDA 510(k) clearance on 2018-01-26. The listed applicant is V2k Medical, Inc.. The 510(k) number is K172716.

When did V2K Rinspiration System receive FDA 510(k) clearance?

V2K Rinspiration System received FDA 510(k) clearance on 2018-01-26, under 510(k) number K172716.

Who is the listed applicant for V2K Rinspiration System?

The FDA 510(k) record lists V2k Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for V2K Rinspiration System?

The FDA product code for V2K Rinspiration System 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

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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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