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FDA 510(k)

BASIXTOUCH

K-Number: K130566 · 2013-06-19

ApplicantMerit Medical Systems, Inc.
Decision Date2013-06-19
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BASIXTOUCH is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2013-06-19 under 510(k) number K130566. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BASIXTOUCH?

BASIXTOUCH is a medical device that received FDA 510(k) clearance on 2013-06-19. The listed applicant is Merit Medical Systems, Inc.. The 510(k) number is K130566.

When did BASIXTOUCH receive FDA 510(k) clearance?

BASIXTOUCH received FDA 510(k) clearance on 2013-06-19, under 510(k) number K130566.

Who is the listed applicant for BASIXTOUCH?

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

What is the FDA product code for BASIXTOUCH?

The FDA product code for BASIXTOUCH is MAV.

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Related Devices (Code: MAV)

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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