K221707 is an FDA 510(k) clearance for the SafeSept® Transseptal Guidewire (SS-140). This device is classified as a Trocar (Class II - Special Controls, product code DRC).
Submitted by Pressure Products Medical Device Manufacturing, LLC (Morton, US). The FDA issued a Cleared decision on September 14, 2022, 93 days after receiving the submission on June 13, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K221707 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 2022 |
| Decision Date | September 14, 2022 |
| Days to Decision | 93 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRC — Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |