K232037 is an FDA 510(k) clearance for the Reprocessed VersaCross Steerable Sheath. This device is classified as a Reprocessed Catheter Introducer (Class II - Special Controls, product code PNE).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on April 4, 2024, 269 days after receiving the submission on July 10, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1340. Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System.
| 510(k) Number | K232037 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 10, 2023 |
| Decision Date | April 04, 2024 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PNE — Reprocessed Catheter Introducer |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1340 |
| Definition | Introduce Various Cardiovascular Catheters Into The Heart And Cardiovascular System |