FDA.report

510(k) K241156

Device
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, 401
Applicant
Surgical Instrument Service and Savings, Inc.
510(k) number
K241156
Product code
NLH
Decision
Substantially Equivalent (SESE)
Decision date
2024-09-14
Date received
2024-04-26
Regulation
870.1220
Classification name
Catheter, Recording, Electrode, Reprocessed
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Stephanie Boyle Mays
Address
(Dba Medline Renewal) 1500 NE Hemlock Ave. Redmond OR US 97756 97756

FDA Registration Numbers

Source Documents

510(k) summary PDF

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K191170Reprocessed Reflexion Spiral Bi-Directional Variable Radius Electrophysiology CatheterInnovative Health, LLC2019-10-30
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