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, 40
FDA 510(k) K241156 · Surgical Instrument Service and Savings, Inc.
510(k) numberK241156
Submission
- Device name
- 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, 40
- Applicant
- Surgical Instrument Service and Savings, Inc.
Redmond, OR, US - Received
- April 26, 2024
- Decision date
- September 14, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NLH – Catheter, Recording, Electrode, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
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).
Other 510(k)s with product code NLH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 11/26/2025SE |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 07/11/2025SE |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNLH · Traditional | Surgical Instrument Service and Savings, Inc. | 11/29/2024SE |
| K241224 | Medline ReNewal Reprocessed Biosense Webster Webster CS Catheter with EZ Steer…NLH · Traditional | Surgical Instrument Service and Savings Inc.(Dba… | 11/15/2024SE |
| K240826 | Reprocessed DECANAV Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar…NLH · Traditional | Sterilmed, Inc. | 10/11/2024SE |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 06/07/2024SE |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterNLH · Traditional | Innovative Health | 06/07/2024SE |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterNLH · Traditional | Surgical Instrument Service and Savings, Inc. | 05/31/2023SE |
| K221854 | Reprocesses Umbilical CableNLH · Traditional | Innovative Health, LLC | 08/06/2022SE |
| K211276 | Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology CathetersNLH · Traditional | Innovative Health, LLC | 09/15/2021SE |
More from Innovative Health, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K250314 | Medline ReNewal Reprocessed Abbott Agilis Nxt Steerable IntroducerPNE · Traditional | 12/19/2025SE |
| K252405 | Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable…NLH · Traditional | 11/26/2025SE |
| K250772 | Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable…NLH · Traditional | 07/11/2025SE |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…OWQ · Traditional | 06/05/2025SE |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens…OWQ · Traditional | 03/10/2025SE |
| K242225 | Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic CatheterNLH · Traditional | 11/29/2024SE |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens…OWQ · Traditional | 09/10/2024SE |
| K240972 | Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)NLH · Traditional | 06/07/2024SE |
| K232511 | Medline ReNewal Reprocessed LigaSure Exact Dissector, Nano-coated (LF2019)NUJ · Traditional | 04/29/2024SE |
| K221067 | Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology CatheterNLH · Traditional | 05/31/2023SE |
Questions and answers
When was 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, 40 cleared by the FDA?
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, 40 (K241156) received a 510(k) decision of Substantially Equivalent on September 14, 2024, 141 days after the submission was received.
What is the product code of K241156?
The FDA product code is NLH – Catheter, Recording, Electrode, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1220.