K192998 is an FDA 510(k) clearance for the Reprocessed BRK Transseptal Needle. This device is classified as a Trocar, Reprocessed (Class II - Special Controls, product code NMK).
Submitted by Innovative Health, LLC (Scottsdale, US). The FDA issued a Cleared decision on July 22, 2020, 268 days after receiving the submission on October 28, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390. 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 | K192998 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 2019 |
| Decision Date | July 22, 2020 |
| Days to Decision | 268 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | NMK — Trocar, Reprocessed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |
| 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). |