Cleared Traditional

K240972 - Medline ReNewal Reprocessed Medtronic A...

K240972 is the FDA 510(k) clearance for Medline ReNewal Reprocessed Medtronic A... by Surgical Instrument Service and Savings, Inc.. It is a Class 2 Cardiovascular device (product code NLH) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K240972 · Surgical Instrument Service and Savings, Inc. · Cardiovascular device
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Jun 2024
Decision
59d
Days
Class 2
Risk

K240972 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC). Classified as Catheter, Recording, Electrode, Reprocessed (product code NLH), Class II - Special Controls.

Submitted by Surgical Instrument Service and Savings, Inc. (Redmond, US). The FDA issued a Cleared decision on June 7, 2024 after a review of 59 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Surgical Instrument Service and Savings, Inc. devices

Submission Details

510(k) Number K240972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 2024
Decision Date June 07, 2024
Days to Decision 59 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
66d faster than avg
Panel avg: 125d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NLH Catheter, Recording, Electrode, Reprocessed
Device Class Class 2 - 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).
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.

Regulatory Peers - NLH Catheter, Recording, Electrode, Reprocessed

All 51
Devices cleared under the same product code (NLH) and FDA review panel - the closest regulatory comparables to K240972.
Reprocessed DECANAV™ Electrophysiology Catheter
K240826 · Sterilmed, Inc. · Oct 2024
Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter, Supreme Electrophysiology Catheter (401150, 401206, 401207, 401210, 401211, 401212, 401222, 401223, 401226, 401227, 401228, 401260, 401261, 401271, 401305, 401306, 401309, 401310, 401311, 401312, 401317, 401353, 401357, 401381, 401392, 401399, 401400, 401425, 401430, 401433, 401434, 401435, 401436, 401438, 401441, 401442, 401443, 401444, 401445, 401448, 401449, 401450, 401451, 401453, 401466, 401468, 401
K241156 · Surgical Instrument Service and Savings, Inc. · Sep 2024
Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
K233825 · Innovative Health · Jun 2024
Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
K221067 · Surgical Instrument Service and Savings, Inc. · May 2023
Reprocesses Umbilical Cable
K221854 · Innovative Health, LLC · Aug 2022
Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
K211276 · Innovative Health, LLC · Sep 2021