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FDA 510(k)

Scepter Mini Occlusion Balloon Catheter

K-Number: K182829 · 2019-07-10

ApplicantMicroVention, Inc.
Decision Date2019-07-10
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Scepter Mini Occlusion Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is MicroVention, Inc.. It received FDA 510(k) clearance on 2019-07-10 under 510(k) number K182829. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Scepter Mini Occlusion Balloon Catheter?

Scepter Mini Occlusion Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-07-10. The listed applicant is MicroVention, Inc.. The 510(k) number is K182829.

When did Scepter Mini Occlusion Balloon Catheter receive FDA 510(k) clearance?

Scepter Mini Occlusion Balloon Catheter received FDA 510(k) clearance on 2019-07-10, under 510(k) number K182829.

Who is the listed applicant for Scepter Mini Occlusion Balloon Catheter?

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

What is the FDA product code for Scepter Mini Occlusion Balloon Catheter?

The FDA product code for Scepter Mini Occlusion Balloon Catheter is DQY.

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 CatheterCOMPLETEDNCT07678164A Randomized Trial of Carotid Artery Stenting With Balloon Guide CatheterNOT_YET_RECRUITING

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Related Devices (Code: DQY)

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.

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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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