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FDA 510(k)

SCOUT BX Delivery System

K-Number: K212882 · 2022-04-08

ApplicantMerit Medical Systems, Inc.
Decision Date2022-04-08
Product CodeNEU
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

SCOUT BX Delivery System is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2022-04-08 under approval number K212882. The device is classified under product code NEU. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SCOUT BX Delivery System?

SCOUT BX Delivery System is a medical device that received FDA 510(k) clearance on 2022-04-08. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K212882.

When was SCOUT BX Delivery System approved by the FDA?

SCOUT BX Delivery System received FDA 510(k) clearance on 2022-04-08, under approval number K212882.

What company makes SCOUT BX Delivery System?

SCOUT BX Delivery System is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for SCOUT BX Delivery System?

The FDA product code for SCOUT BX Delivery System is NEU.

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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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