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FDA 510(k)

ANGIOJET SOLENT DISTA THROMBECTOMY SET

K-Number: K113363 · 2012-06-06

ApplicantMedrad, Inc.
Decision Date2012-06-06
Product CodeQEZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOJET SOLENT DISTA THROMBECTOMY SET is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2012-06-06 under 510(k) number K113363. The device is classified under product code QEZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANGIOJET SOLENT DISTA THROMBECTOMY SET?

ANGIOJET SOLENT DISTA THROMBECTOMY SET is a medical device that received FDA 510(k) clearance on 2012-06-06. The listed applicant is Medrad, Inc.. The 510(k) number is K113363.

When did ANGIOJET SOLENT DISTA THROMBECTOMY SET receive FDA 510(k) clearance?

ANGIOJET SOLENT DISTA THROMBECTOMY SET received FDA 510(k) clearance on 2012-06-06, under 510(k) number K113363.

Who is the listed applicant for ANGIOJET SOLENT DISTA THROMBECTOMY SET?

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

What is the FDA product code for ANGIOJET SOLENT DISTA THROMBECTOMY SET?

The FDA product code for ANGIOJET SOLENT DISTA THROMBECTOMY SET is QEZ.

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Other records listing Medrad, 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.

K130381ANGIOJET ULTRA POWER PULSE KITK130637JETSTREAM XC 2.4/3.4 SYSTEM; JETSTREAM XC 2.1/3.0 SYSTEM; JETSTREAM SC 1.85 SYSTEM; JETSTREAM SC 1.6 SYSTEMK122916JETSTREAM NAVITUS L SYSTEM JEYSTREAM NAVITUS SYSTEM JETSTREAM G3 SF SYSTEM JETSTREAM SF 1.6 SYSTEMK113133MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM), (TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION ARTERION SYRINGEK113428ANGIOJET ULTRA DVX THROMBECTOMY SETK112086MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE

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Related Devices (Code: QEZ)

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.

K254035Mayumi™ Thrombectomy SystemMicroVention, Inc., d/b/a Terumo NeuroK261105Powered Aventus Thrombectomy System™Inquis MedicalK262030Aventus Thrombectomy SystemInquis MedicalK253589Liberant™ RX Aspiration CatheterMedtronic Interventional Vascular, Inc.K254208FLOWRUNNER Aspiration SystemExpanse Medical, Inc.K253925Aventus Thrombectomy SystemInquis Medical

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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