Cleared Traditional

Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT)

K241224 · Surgical Instrument Service and Savings Inc.(Dba Medline Ren · Cardiovascular

Nov 2024

Decision

197d

Days

Class 2

Risk

About This 510(k) Submission

K241224 is an FDA 510(k) clearance for the Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer Technology and Auto ID Technology (BD710DF282CT, BD710DF282RTS, BD710FJ282RTS, BD710FJ282CT), a Catheter, Recording, Electrode, Reprocessed (Class II — Special Controls, product code NLH), submitted by Surgical Instrument Service and Savings Inc.(Dba Medline Ren (Redmond, US). The FDA issued a Cleared decision on November 15, 2024, 197 days after receiving the submission on May 2, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number	K241224 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 02, 2024
Decision Date	November 15, 2024
Days to Decision	197 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).