S-MAK XL
K-Number: K190175 · 2019-04-10
ApplicantMerit Medical Systems, Inc.
Decision Date2019-04-10
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
S-MAK XL is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-04-10 under approval number K190175. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the S-MAK XL?
S-MAK XL is a medical device that received FDA 510(k) clearance on 2019-04-10. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K190175.
When was S-MAK XL approved by the FDA?
S-MAK XL received FDA 510(k) clearance on 2019-04-10, under approval number K190175.
What company makes S-MAK XL?
S-MAK XL is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for S-MAK XL?
The FDA product code for S-MAK XL is DRE.
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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.