Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters— 510(k) K231015

Name: FDA 510(k) clearance K231015
Creator: U.S. Food and Drug Administration
Published: 2024-07-01

Substantially Equivalent

Innovative Health, LLC

FDA 510(k) clearance K231015 for Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters, Substantially Equivalent on 2024-07-01. Applicant: Innovative Health, LLC. Device class: 2.

Clearance details

Applicant: Innovative Health, LLC
Product code: Code NLI
Device class: Class 2
Regulation: 21 CFR 870.1200
Advisory panel: Cardiovascular
Date received: 2023-04-10
Decision date: 2024-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Scottsdale, AZ, US

Download summary PDF View on FDA.gov ↗

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