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FDA 510(k)

SCEPTER XC OCCLUSION BALLOON CATHETER

K-Number: K113698 · 2012-01-13

ApplicantMicroVention, Inc.
Decision Date2012-01-13
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SCEPTER XC 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 2012-01-13 under 510(k) number K113698. 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 SCEPTER XC OCCLUSION BALLOON CATHETER?

SCEPTER XC OCCLUSION BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2012-01-13. The listed applicant is MicroVention, Inc.. The 510(k) number is K113698.

When did SCEPTER XC OCCLUSION BALLOON CATHETER receive FDA 510(k) clearance?

SCEPTER XC OCCLUSION BALLOON CATHETER received FDA 510(k) clearance on 2012-01-13, under 510(k) number K113698.

Who is the listed applicant for SCEPTER XC 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 XC OCCLUSION BALLOON CATHETER?

The FDA product code for SCEPTER XC OCCLUSION BALLOON CATHETER is MJN.

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Related Devices (Code: MJN)

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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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