Reprocessed CS Bi-Diectional Diagnostic Electrophysiology Catheter
FDA 510(k) K100254 · Ascent Healthcare Solutions
510(k) numberK100254
Submission
- Device name
- Reprocessed CS Bi-Diectional Diagnostic Electrophysiology Catheter
- Applicant
- Ascent Healthcare Solutions
Phoenix, AZ, US - Received
- January 28, 2010
- Decision date
- May 28, 2010
- 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 |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 09/14/2024SE |
| 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 |
More from Innovative Health, LLC
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| K111600 | Reprocessed Hand Activate Sealer/DividerNUJ · Traditional | 11/15/2011SE |
| K110189 | Reprocessed Electrosurgical InstrumentNUJ · Traditional | 07/18/2011SE |
| K100909 | Reprocessed Compression SleevesJOW · Traditional | 07/23/2010SE |
| K100537 | Reprocessed Ultrasonic Curved Shears with Torque Wrench and Grip Assist Model FCS9…NLQ · Traditional | 05/12/2010SE |
| K100080 | Reprocessed Trocars, Model B5LT and CB5LTNLM · Traditional | 03/19/2010SE |
| K093702 | Reprocessed Ultrasonic Coagulating ShearsNLQ · Traditional | 03/04/2010SE |
| K092425 | Reprocessed 3D Diagnostic Ultrasound Catheters, Model SNDSTR10OWQ · Traditional | 10/21/2009SE |
| K090323 | Reprocessed Electrophysiology CathetersNLH · Traditional | 04/01/2009SE |
| K082023 | Reprocessed Electrophysiology CathetersNLH · Traditional | 09/16/2008SE |
| K081238 | Reprocessed Masimo Pulse Oximeter SensorsNLF · Traditional | 07/29/2008SE |
Questions and answers
When was Reprocessed CS Bi-Diectional Diagnostic Electrophysiology Catheter cleared by the FDA?
Reprocessed CS Bi-Diectional Diagnostic Electrophysiology Catheter (K100254) received a 510(k) decision of Substantially Equivalent on May 28, 2010, 120 days after the submission was received.
What is the product code of K100254?
The FDA product code is NLH – Catheter, Recording, Electrode, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1220.