Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
FDA 510(k) K240972 · Surgical Instrument Service and Savings, Inc.
510(k) numberK240972
Submission
- Device name
- Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC)
- Applicant
- Surgical Instrument Service and Savings, Inc.
Redmond, OR, US - Received
- April 9, 2024
- Decision date
- June 7, 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 |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…NLH · Traditional | Surgical Instrument Service and Savings, Inc. | 09/14/2024SE |
| 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 |
| K241156 | Medline ReNewal Reprocessed St. Jude Medical Response Electrophysiology Catheter…NLH · Traditional | 09/14/2024SE |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens…OWQ · Traditional | 09/10/2024SE |
| 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 Medtronic Achieve Catheter Connecting Cable (2ACHC) cleared by the FDA?
Medline ReNewal Reprocessed Medtronic Achieve Catheter Connecting Cable (2ACHC) (K240972) received a 510(k) decision of Substantially Equivalent on June 7, 2024, 59 days after the submission was received.
What is the product code of K240972?
The FDA product code is NLH – Catheter, Recording, Electrode, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1220.