Starlight Imaging Catheter— 510(k) K243016

Substantially Equivalent

Spectrawave, Inc.

FDA 510(k) clearance K243016 for Starlight Imaging Catheter, Substantially Equivalent on 2025-03-20. Applicant: Spectrawave, Inc..

Clearance details

Applicant: Spectrawave, Inc.
Product code: Code NQQ
Advisory panel: Radiology
Date received: 2024-09-27
Decision date: 2025-03-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Bedford, MA, US

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