Cleared Traditional

K212165 - Reprocessed Carto Vizigo Bi-Directional Guiding Sheath (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K212165 · Innovative Health, LLC · Cardiovascular device
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Mar 2022
Decision
241d
Days
Class 2
Risk

K212165 is an FDA 510(k) clearance for the Reprocessed Carto Vizigo Bi-Directional Guiding Sheath. Classified as Reprocessed Catheter Introducer (product code PNE), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on March 10, 2022 after a review of 241 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Health, LLC devices

Submission Details

510(k) Number K212165 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 2021
Decision Date March 10, 2022
Days to Decision 241 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 125d · This submission: 241d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PNE Reprocessed Catheter Introducer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
Definition Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - PNE Reprocessed Catheter Introducer

Devices cleared under the same product code (PNE) and FDA review panel - the closest regulatory comparables to K212165.
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K232037 · Innovative Health, LLC · Apr 2024
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K230376 · Innovative Health, LLC · Aug 2023