Reprocessed Electrophysiology Catheters
FDA 510(k) K061045 · Alliance Medical Corp.
510(k) numberK061045
Submission
- Device name
- Reprocessed Electrophysiology Catheters
- Applicant
- Alliance Medical Corp.
Phoenix, AZ, US - Received
- April 14, 2006
- Decision date
- August 31, 2006
- 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
| 510(k) | Device | Decision |
|---|---|---|
| K060648 | Reprocessed Phacoemulsification TipsNKX · Traditional | 03/19/2007SE |
| K051438 | Vanguard Reprocessed Compression Garments (Hill-Rom)JOW · Traditional | 04/04/2006SE |
| K060049 | Reprocessed Compression SleevesJOW · Traditional | 02/24/2006SE |
| K060091 | Alliance Medical Corporation Reprocessed Compression SleevesJOW · Traditional | 02/17/2006SE |
| K053316 | Reprocessed Compression SleevesJOW · Traditional | 02/13/2006SE |
| K052918 | Reprocessed External Fixation DevicesKTT · Traditional | 01/27/2006SE |
| K052603 | Reprocessed Daig Livewire Electrophysiology CathetersNLH · Traditional | 11/16/2005SE |
| K052414 | Reprocessed Electrophysiology CatheterNLH · Traditional | 11/16/2005SE |
| K050518 | Reprocessed Phacoemuisification TipsNKX · Traditional | 09/23/2005SE |
| K052064 | Alliance Medical Corporation Reprocessed External Fixation DevicesKTT · Special | 08/25/2005SE |
Questions and answers
When was Reprocessed Electrophysiology Catheters cleared by the FDA?
Reprocessed Electrophysiology Catheters (K061045) received a 510(k) decision of Substantially Equivalent on August 31, 2006, 139 days after the submission was received.
What is the product code of K061045?
The FDA product code is NLH – Catheter, Recording, Electrode, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1220.