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FDA 510(k)

Sniper Infusion Catheter with Balloon Occlusion

K-Number: K180904 · 2018-06-08

ApplicantEmbolx, Inc.
Decision Date2018-06-08
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sniper Infusion Catheter with Balloon Occlusion is the device name listed in this FDA 510(k) record. The listed applicant is Embolx, Inc.. It received FDA 510(k) clearance on 2018-06-08 under 510(k) number K180904. 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 Sniper Infusion Catheter with Balloon Occlusion?

Sniper Infusion Catheter with Balloon Occlusion is a medical device that received FDA 510(k) clearance on 2018-06-08. The listed applicant is Embolx, Inc.. The 510(k) number is K180904.

When did Sniper Infusion Catheter with Balloon Occlusion receive FDA 510(k) clearance?

Sniper Infusion Catheter with Balloon Occlusion received FDA 510(k) clearance on 2018-06-08, under 510(k) number K180904.

Who is the listed applicant for Sniper Infusion Catheter with Balloon Occlusion?

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

What is the FDA product code for Sniper Infusion Catheter with Balloon Occlusion?

The FDA product code for Sniper Infusion Catheter with Balloon Occlusion 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.

NCT06798753Occlusion Balloon vs. 5FR Ureteral CatheterCOMPLETEDNCT07585188Neonatal Catheter Lock for Infection PreventionNOT_YET_RECRUITINGNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

Other records listing Embolx, 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.

K232536Soldier Microcatheter

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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