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FDA 510(k)

REBOA Balloon Catheter

K-Number: K160598 · 2016-06-20

ApplicantNuMED, Inc.
Decision Date2016-06-20
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REBOA Balloon Catheter is a medical device manufactured by NuMED, Inc.. It received FDA 510(k) clearance on 2016-06-20 under approval number K160598. 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 REBOA Balloon Catheter?

REBOA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-06-20. It is manufactured by NuMED, Inc.. The 510(k) number is K160598.

When was REBOA Balloon Catheter approved by the FDA?

REBOA Balloon Catheter received FDA 510(k) clearance on 2016-06-20, under approval number K160598.

What company makes REBOA Balloon Catheter?

REBOA Balloon Catheter is manufactured by NuMED, Inc..

What is the FDA product code for REBOA Balloon Catheter?

The FDA product code for REBOA Balloon Catheter is MJN.

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Related Devices (Code: MJN)

K153530Bridge Occlusion BalloonSpectranetics, Inc. K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. K172790ER-REBOA CatheterPrytime Medical Devices, Inc. K170411ER-REBOA CatheterPrytime Medical Devices, Inc. K160067RenovoCathRenovorx, Inc. K182916Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 FrLemaitre Vascular

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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