Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
FDA 510(k) K160421 · Innovative Health, LLC
510(k) numberK160421
Submission
- Device name
- Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter
- Applicant
- Innovative Health, LLC
Scottsdale, AZ, US - Received
- February 16, 2016
- Decision date
- November 2, 2016
- 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 |
|---|---|---|
| K250305 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | 01/07/2026SE |
| K231015 | Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersNLI · Traditional | 07/01/2024SE |
| K233825 | Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterNLH · Traditional | 06/07/2024SE |
| K232037 | Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathPNE · Traditional | 04/04/2024SE |
| K230376 | Reprocessed Agilis NxT Steerable IntroducerPNE · Traditional | 08/07/2023SE |
| K213584 | Reprocessed NRG Transseptal NeedleQLZ · Traditional | 04/04/2023SE |
| K221854 | Reprocesses Umbilical CableNLH · Traditional | 08/06/2022SE |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS CatheterOWQ · Traditional | 05/25/2022SE |
| K212165 | Reprocessed Carto Vizigo Bi-Directional Guiding SheathPNE · Traditional | 03/10/2022SE |
| K212776 | Reprocessed Advisor HD Grid Mapping Catheter, Sensor EnabledNLG · Traditional | 12/20/2021SE |
Questions and answers
When was Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter cleared by the FDA?
Reprocessed Inquiry Optima Plus Steerable Diagnostic EP Catheter, Reprocessed Inquiry Optima Steerable Diagnostic EP Catheter (K160421) received a 510(k) decision of Substantially Equivalent on November 2, 2016, 260 days after the submission was received.
What is the product code of K160421?
The FDA product code is NLH – Catheter, Recording, Electrode, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.1220.