Reprocessed NRG Transseptal Needle
FDA 510(k) K200060 · Innovative Health, LLC
510(k) numberK200060
Submission
- Device name
- Reprocessed NRG Transseptal Needle
- Applicant
- Innovative Health, LLC
Scottsdale, AZ, US - Received
- January 13, 2020
- Decision date
- July 30, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QLZ – Septostomy Catheter, Reprocessed
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5175
- Specialty
- Cardiovascular
To create or enlarge an atrial septal defect in the heart.
Other 510(k)s with product code QLZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K213584 | Reprocessed NRG Transseptal NeedleQLZ · Traditional | Innovative Health, LLC | 04/04/2023SE |
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 NRG Transseptal Needle cleared by the FDA?
Reprocessed NRG Transseptal Needle (K200060) received a 510(k) decision of Substantially Equivalent on July 30, 2020, 199 days after the submission was received.
What is the product code of K200060?
The FDA product code is QLZ – Septostomy Catheter, Reprocessed, a Class II (moderate risk) device regulated under 21 CFR 870.5175.