HYBRID Guidewire
K-Number: K182337 · 2018-10-04
ApplicantBalt USA, LLC
Decision Date2018-10-04
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
HYBRID Guidewire is a medical device manufactured by Balt USA, LLC. It received FDA 510(k) clearance on 2018-10-04 under approval number K182337. The device is classified under product code MOF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HYBRID Guidewire?
HYBRID Guidewire is a medical device that received FDA 510(k) clearance on 2018-10-04. It is manufactured by Balt USA, LLC. The 510(k) number is K182337.
When was HYBRID Guidewire approved by the FDA?
HYBRID Guidewire received FDA 510(k) clearance on 2018-10-04, under approval number K182337.
What company makes HYBRID Guidewire?
HYBRID Guidewire is manufactured by Balt USA, LLC.
What is the FDA product code for HYBRID Guidewire?
The FDA product code for HYBRID Guidewire is MOF.
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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.