Cleared Traditional

Reprocessed NRG Transseptal Needle

K200060 · Innovative Health, LLC · Cardiovascular

Jul 2020

Decision

199d

Days

Class 2

Risk

About This 510(k) Submission

K200060 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 July 30, 2020, 199 days after receiving the submission on January 13, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5175.

Submission Details

510(k) Number	K200060 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 13, 2020
Decision Date	July 30, 2020
Days to Decision	199 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.