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FDA 510(k)

HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315

K-Number: K092495 · 2009-09-22

ApplicantEv3 Neurovascular
Decision Date2009-09-22
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 is the device name listed in this FDA 510(k) record. The listed applicant is Ev3 Neurovascular. It received FDA 510(k) clearance on 2009-09-22 under 510(k) number K092495. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315?

HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 is a medical device that received FDA 510(k) clearance on 2009-09-22. The listed applicant is Ev3 Neurovascular. The 510(k) number is K092495.

When did HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 receive FDA 510(k) clearance?

HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 received FDA 510(k) clearance on 2009-09-22, under 510(k) number K092495.

Who is the listed applicant for HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315?

The FDA 510(k) record lists Ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315?

The FDA product code for HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 is MJN.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Ev3 Neurovascular 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.

K093681MERIDIAN GUIDEWIREK091458HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104

Related Devices (Code: MJN)

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.

K243795pREBOA-PRO CatheterPrytime Medical Devices, Inc.K251358Bridge Plus Occlusion Balloon (590-002)Philips Image Guided Therapy DevicesK221294preCARDIA Occlusion SystemAbiomed, Inc.K214060LANDMARK REBOA CatheterZien Medical Technologies, Inc.K211610Fogarty Occlusion CatheterEdwards Lifesciences, LLCK212324RenovoCathRenovorx, Inc.

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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