K213584 is an FDA 510(k) clearance for the Reprocessed NRG Transseptal Needle. This device is classified as a Septostomy Catheter, Reprocessed (Class II - Special Controls, product code QLZ).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on April 4, 2023, 508 days after receiving the submission on November 12, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5175. To Create Or Enlarge An Atrial Septal Defect In The Heart..
| 510(k) Number | K213584 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 12, 2021 |
| Decision Date | April 04, 2023 |
| Days to Decision | 508 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QLZ — Septostomy Catheter, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5175 |
| Definition | To Create Or Enlarge An Atrial Septal Defect In The Heart. |