Steerable catheter control system— 510(k) K183027

Substantially Equivalent

Stereotaxis, Inc.

FDA 510(k) clearance K183027 for Steerable catheter control system, Substantially Equivalent on 2019-09-06. Applicant: Stereotaxis, Inc..

Clearance details

Applicant: Stereotaxis, Inc.
Product code: Code PJB
Advisory panel: Cardiovascular
Date received: 2018-11-01
Decision date: 2019-09-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, US

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