SureLead Cable System
K-Number: K181089 · 2020-01-17
ApplicantAuthentic Medical
Decision Date2020-01-17
Product CodeDSA
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
SureLead Cable System is a medical device manufactured by Authentic Medical. It received FDA 510(k) clearance on 2020-01-17 under approval number K181089. The device is classified under product code DSA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the SureLead Cable System?
SureLead Cable System is a medical device that received FDA 510(k) clearance on 2020-01-17. It is manufactured by Authentic Medical. The 510(k) number is K181089.
When was SureLead Cable System approved by the FDA?
SureLead Cable System received FDA 510(k) clearance on 2020-01-17, under approval number K181089.
What company makes SureLead Cable System?
SureLead Cable System is manufactured by Authentic Medical.
What is the FDA product code for SureLead Cable System?
The FDA product code for SureLead Cable System is DSA.
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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.