Cleared Traditional

K231015 - Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters

K231015 is an FDA 510(k) clearance for Reprocessed Super Torque and Super Torq..., manufactured by Innovative Health, LLC. The device is a Class 2 Cardiovascular device with product code NLI cleared through the Traditional 510(k) pathway after a 448-day FDA review.

K231015 · Innovative Health, LLC · Cardiovascular device
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Jul 2024
Decision
448d
Days
Class 2
Risk

K231015 is an FDA 510(k) clearance for the Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters. Classified as Catheter, Angiography, Reprocessed (product code NLI), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on July 1, 2024 after a review of 448 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Innovative Health, LLC devices

FDA 510(k) Submission Details - K231015

510(k) Number K231015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 2023
Decision Date July 01, 2024
Days to Decision 448 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
323d slower than avg
Panel avg: 125d · This submission: 448d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NLI Device Classification - Class 2, Special Controls

Product Code NLI Catheter, Angiography, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
Definition Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission. (70 Fr 56911, Available At Https://www.govinfo.gov/content/pkg/fr-2005-09-29/pdf/05-19510.pdf).
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.