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FDA 510(k)

ANGIOJET ULTRA POWER PULSE KIT

K-Number: K130381 · 2013-07-29

ApplicantMedrad, Inc.
Decision Date2013-07-29
Product CodeQEW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ANGIOJET ULTRA POWER PULSE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Medrad, Inc.. It received FDA 510(k) clearance on 2013-07-29 under 510(k) number K130381. 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 ANGIOJET ULTRA POWER PULSE KIT?

ANGIOJET ULTRA POWER PULSE KIT is a medical device that received FDA 510(k) clearance on 2013-07-29. The listed applicant is Medrad, Inc.. The 510(k) number is K130381.

When did ANGIOJET ULTRA POWER PULSE KIT receive FDA 510(k) clearance?

ANGIOJET ULTRA POWER PULSE KIT received FDA 510(k) clearance on 2013-07-29, under 510(k) number K130381.

Who is the listed applicant for ANGIOJET ULTRA POWER PULSE KIT?

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 ULTRA POWER PULSE KIT?

The FDA product code for ANGIOJET ULTRA POWER PULSE KIT is QEW.

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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.

K253419Triever Duo CatheterInari Medical, Inc.K261800Helo Max Thrombectomy System (HEL2090)Endovascular EngineeringK262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.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.

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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