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FDA 510(k)

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 the device name listed in this FDA 510(k) record. The listed applicant is C-Rad Positioning AB. It received FDA 510(k) clearance on 2020-05-07 under 510(k) 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. The listed applicant is C-Rad Positioning AB. The 510(k) number is K200435.

When did Catalyst+, Catalyst+ HD receive FDA 510(k) clearance?

Catalyst+, Catalyst+ HD received FDA 510(k) clearance on 2020-05-07, under 510(k) number K200435.

Who is the listed applicant for Catalyst+, Catalyst+ HD?

The FDA 510(k) record lists C-Rad Positioning AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Catalyst+, Catalyst+ HD?

The FDA product code for Catalyst+, Catalyst+ HD is IYE.

Other records listing C-Rad Positioning AB as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K200600Sentinel

Related Devices (Code: IYE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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