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FDA 510(k)

Vortex Radial Spray Catheter

K-Number: K201183 · 2020-12-07

ApplicantCSA Medical, Inc.
Decision Date2020-12-07
Product CodeGEH
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Vortex Radial Spray Catheter is the device name listed in this FDA 510(k) record. The listed applicant is CSA Medical, Inc.. It received FDA 510(k) clearance on 2020-12-07 under 510(k) number K201183. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Vortex Radial Spray Catheter?

Vortex Radial Spray Catheter is a medical device that received FDA 510(k) clearance on 2020-12-07. The listed applicant is CSA Medical, Inc.. The 510(k) number is K201183.

When did Vortex Radial Spray Catheter receive FDA 510(k) clearance?

Vortex Radial Spray Catheter received FDA 510(k) clearance on 2020-12-07, under 510(k) number K201183.

Who is the listed applicant for Vortex Radial Spray Catheter?

The FDA 510(k) record lists CSA Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Vortex Radial Spray Catheter?

The FDA product code for Vortex Radial Spray Catheter is GEH.

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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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