Cleared Traditional

K213584 - Reprocessed NRG Transseptal Needle (FDA 510(k) Clearance)

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

K213584 · Innovative Health, LLC · Cardiovascular device
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Apr 2023
Decision
508d
Days
Class 2
Risk

K213584 is an FDA 510(k) clearance for the Reprocessed NRG Transseptal Needle. Classified as Septostomy Catheter, Reprocessed (product code QLZ), Class II - Special Controls.

Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on April 4, 2023 after a review of 508 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5175 - 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

Submission Details

510(k) Number K213584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 2021
Decision Date April 04, 2023
Days to Decision 508 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
383d slower than avg
Panel avg: 125d · This submission: 508d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QLZ Septostomy Catheter, Reprocessed
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5175
Definition To Create Or Enlarge An Atrial Septal Defect In The Heart.
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.