Cleared Traditional

Reprocesses Umbilical Cable

K221854 · Innovative Health, LLC · Cardiovascular
Aug 2022
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K221854 is an FDA 510(k) clearance for the Reprocesses Umbilical Cable, a Catheter, Recording, Electrode, Reprocessed (Class II — Special Controls, product code NLH), submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on August 6, 2022, 40 days after receiving the submission on June 27, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K221854 FDA.gov
FDA Decision Cleared SESE
Date Received June 27, 2022
Decision Date August 06, 2022
Days to Decision 40 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code NLH — Catheter, Recording, Electrode, Reprocessed
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220
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).

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