Chrysalis Intelligence · Product Codes · NLH

NLH · Catheter, Recording, Electrode, Reprocessed

Cardiovascular · 14 clearances · 5 unique sponsors

Device class
Class II
Regulation 870.1220
Total clearances
14
2020-01-24 → 2025-11-26
Last 12 months
1
Unique sponsors
5
Definition

What is Catheter, Recording, Electrode, Reprocessed

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).
Medical specialty
Cardiovascular
Review panel
CV
Regulation number
870.1220
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
N
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Surgical Instrument Service and Savings, Inc. 6 1 2025-11-26
Innovative Health, LLC 5 0 2024-06-07
Stryker Sustainability Solutions 1 0 2020-05-13
Surgical Instrument Service and Savings Inc.(Dba Medline Ren 1 0 2024-11-15
Sterilmed, Inc. 1 0 2024-10-11
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
93600 CPT Medium Intracardiac electrogram recording during catheterization
C1731 HCPCS Catheter, electrophysiology, diagnostic, other than 3d mapping (20 or more electrodes) ✓ CMS-verified description Medium Recording electrode catheter, reprocessed
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2025-11-26 K252405 Surgical Instrument Service and Savings, Inc. Medline ReNewal Reprocessed Boston Scientific Dynamic Tip Unidirectional Steerable Diagnostic Catheter
2025-07-11 K250772 Surgical Instrument Service and Savings, Inc. Medline ReNewal Reprocessed Boston Scientific Dynamic XT Unidirectional Steerable Diagnostic Catheter
2024-11-29 K242225 Surgical Instrument Service and Savings, Inc. Medline ReNewal Reprocessed Abbott Inquiry Steerable Diagnostic Catheter
2024-11-15 K241224 Surgical Instrument Service and Savings Inc.(Dba Medline Ren 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)
2024-10-11 K240826 Sterilmed, Inc. Reprocessed DECANAV™ Electrophysiology Catheter; Reprocessed WEBSTER® Duo-Decapolar Electrophysiology Catheter
2024-09-14 K241156 Surgical Instrument Service and Savings, Inc. 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
2024-06-07 K240972 Surgical Instrument Service and Savings, Inc. Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
2024-06-07 K233825 Innovative Health Reprocessed Webster Duo-Decapolar Diagnostic EP Catheter
2023-05-31 K221067 Surgical Instrument Service and Savings, Inc. Medline ReNewal Reprocessed St. Jude Medical Livewire Steerable Electrophysiology Catheter
2022-08-06 K221854 Innovative Health, LLC Reprocesses Umbilical Cable
2021-09-15 K211276 Innovative Health, LLC Reprocessed Dynamic Tip and XT Steerable Diagnostic Electrophysiology Catheters
2021-05-04 K203655 Innovative Health, LLC Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter, Reprocessed Webster CS Bi-Directional Diagnostic EP Catheter (with Auto ID)
2020-05-13 K200205 Stryker Sustainability Solutions Reprocessed Advisor FL Circular Mapping Catheter, Sensor Enabled
2020-01-24 K193263 Innovative Health, LLC Reprocessed Achieve Catheter Connecting Cable