Catalyst+, Catalyst+ HD
K-Number: K200435 · 2020-05-07
ApplicantC-Rad Positioning AB
Decision Date2020-05-07
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Catalyst+, Catalyst+ HD is a medical device manufactured by C-Rad Positioning AB. It received FDA 510(k) clearance on 2020-05-07 under approval number K200435. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Catalyst+, Catalyst+ HD?
Catalyst+, Catalyst+ HD is a medical device that received FDA 510(k) clearance on 2020-05-07. It is manufactured by C-Rad Positioning AB. The 510(k) number is K200435.
When was Catalyst+, Catalyst+ HD approved by the FDA?
Catalyst+, Catalyst+ HD received FDA 510(k) clearance on 2020-05-07, under approval number K200435.
What company makes Catalyst+, Catalyst+ HD?
Catalyst+, Catalyst+ HD is manufactured by C-Rad Positioning AB.
What is the FDA product code for Catalyst+, Catalyst+ HD?
The FDA product code for Catalyst+, Catalyst+ HD is IYE.
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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.