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FDA 510(k)

Reprocessed Response Diagnostic Electrophysiology Catheters

K-Number: K161827 · 2016-12-08

ApplicantInnovative Health, LLC
Decision Date2016-12-08
Product CodeNLH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed Response Diagnostic Electrophysiology Catheters is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2016-12-08 under approval number K161827. The device is classified under product code NLH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed Response Diagnostic Electrophysiology Catheters?

Reprocessed Response Diagnostic Electrophysiology Catheters is a medical device that received FDA 510(k) clearance on 2016-12-08. It is manufactured by Innovative Health, LLC. The 510(k) number is K161827.

When was Reprocessed Response Diagnostic Electrophysiology Catheters approved by the FDA?

Reprocessed Response Diagnostic Electrophysiology Catheters received FDA 510(k) clearance on 2016-12-08, under approval number K161827.

What company makes Reprocessed Response Diagnostic Electrophysiology Catheters?

Reprocessed Response Diagnostic Electrophysiology Catheters is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed Response Diagnostic Electrophysiology Catheters?

The FDA product code for Reprocessed Response Diagnostic Electrophysiology Catheters is NLH.

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Related PubMed Literature

PMID: 40747091 A decade of review in global regulation and research of artificial intelligence medical devices (2015-2025). Frontiers in medicine (2025) PMID: 40246728 [Analysis of the Core Principles and Key Design and Development Control Factors of Two Typical Point-of-Care Testing Technologies]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025) PMID: 39900769 Regulatory Perspectives for Gene Expression-Based Diagnostic Devices. Methods in molecular biology (Clifton, N.J.) (2025)

Other Devices by Innovative Health, LLC

K162251Reprocessed Viking 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 K160496Reprocessed Inquiry Steerable Diagnostic EP Catheter

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Related Devices (Code: NLH)

K162251Reprocessed Viking Diagnostic Electrophysiology CathetersInnovative Health, LLC K160421Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP CatheterInnovative Health, LLC K161393Reprocessed Orbiter ST Steerable Diagnostic EP CatheterInnovative Health, LLC K161464Reprocessed Dynamic Tip Steerable Diagnostic Electrophysiology CathetersInnovative Health, LLC K153006Reprocessed Lasso NAV eco and Lasso 2515 NAV eco Variable Electrophysiology (EP) CatheterSterilmed, Inc. K160496Reprocessed Inquiry Steerable Diagnostic EP CatheterInnovative Health, LLC

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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