Cleared Traditional

Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter

K242225 · Surgical Instrument Service and Savings, Inc. · Cardiovascular
Nov 2024
Decision
123d
Days
Class 2
Risk

About This 510(k) Submission

K242225 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter, a Catheter, Recording, Electrode, Reprocessed (Class II — Special Controls, product code NLH), submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on November 29, 2024, 123 days after receiving the submission on July 29, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K242225 FDA.gov
FDA Decision Cleared SESE
Date Received July 29, 2024
Decision Date November 29, 2024
Days to Decision 123 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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