K231015 is an FDA 510(k) clearance for the Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic Catheters. This device is classified as a Catheter, Angiography, Reprocessed (Class II - Special Controls, product code NLI).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on July 1, 2024, 448 days after receiving the submission on April 10, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1200. 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)..
| 510(k) Number | K231015 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 10, 2023 |
| Decision Date | July 01, 2024 |
| Days to Decision | 448 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NLI — Catheter, Angiography, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | 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). |