Columbus Guidewire
K-Number: K200374 · 2020-12-14
ApplicantRapid-Medical , Ltd.
Decision Date2020-12-14
Product CodeMOF
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Columbus Guidewire is a medical device manufactured by Rapid-Medical , Ltd.. It received FDA 510(k) clearance on 2020-12-14 under approval number K200374. 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 Columbus Guidewire?
Columbus Guidewire is a medical device that received FDA 510(k) clearance on 2020-12-14. It is manufactured by Rapid-Medical , Ltd.. The 510(k) number is K200374.
When was Columbus Guidewire approved by the FDA?
Columbus Guidewire received FDA 510(k) clearance on 2020-12-14, under approval number K200374.
What company makes Columbus Guidewire?
Columbus Guidewire is manufactured by Rapid-Medical , Ltd..
What is the FDA product code for Columbus Guidewire?
The FDA product code for Columbus Guidewire is MOF.
Other Devices by Rapid-Medical , Ltd.
Related Devices (Code: MOF)
K163154Traxcess 7 Mini XSoft GuidewireMicroVention, Inc.
K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tipAsahi Intecc Co., Ltd.
K161803Traxcess .007 Mini GuidewireMicroVention, Inc.
K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)Asahi Intecc Co., Ltd.
K171613ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tipAsahi Intecc Co., Ltd.
K182337HYBRID GuidewireBalt USA, LLC
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.