Cleared Traditional

Reprocessed NRG Transseptal Needle

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

About This 510(k) Submission

K213584 is an FDA 510(k) clearance for the Reprocessed NRG Transseptal Needle, a Septostomy Catheter, Reprocessed (Class II — Special Controls, product code QLZ), submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on April 4, 2023, 508 days after receiving the submission on November 12, 2021. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number K213584 FDA.gov
FDA Decision Cleared 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

Device Classification

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