Cleared Traditional

Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter

K250772 · Surgical Instrument Service and Savings, Inc. · Cardiovascular
Jul 2025
Decision
120d
Days
Class 2
Risk

About This 510(k) Submission

K250772 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional 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 July 11, 2025, 120 days after receiving the submission on March 13, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K250772 FDA.gov
FDA Decision Cleared SESE
Date Received March 13, 2025
Decision Date July 11, 2025
Days to Decision 120 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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