Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters

K-Number: K231015 · 2024-07-01

ApplicantInnovative Health, LLC
Decision Date2024-07-01
Product CodeNLI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2024-07-01 under approval number K231015. The device is classified under product code NLI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters?

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters is a medical device that received FDA 510(k) clearance on 2024-07-01. It is manufactured by Innovative Health, LLC. The 510(k) number is K231015.

When was Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters approved by the FDA?

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters received FDA 510(k) clearance on 2024-07-01, under approval number K231015.

What company makes Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters?

Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters?

The FDA product code for Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters is NLI.

Related Clinical Trials

NCT07214220 Intravascular Neuro OCT Imaging System for Aneurysm Treatment Evaluation RECRUITING NCT06034847 Treatment of Persistent Distal Occlusion After Successful Proximal Recanalization in Thrombectomy WITHDRAWN NCT06556836 "Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization" COMPLETED

Other Devices by Innovative Health, LLC

K162251Reprocessed Viking Diagnostic Electrophysiology Catheters K161827Reprocessed Response Diagnostic Electrophysiology Catheters K161769Reprocessed Supreme Diagnostic Electrophysiology Catheters K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter K161393Reprocessed Orbiter ST Steerable Diagnostic EP Catheter K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology Catheters

View all 48 devices →

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.

↑