K170671 is an FDA 510(k) clearance for the SafeSept Transseptal Guidewire. 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 October 20, 2017, 228 days after receiving the submission on March 6, 2017.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K170671 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 06, 2017 |
| Decision Date | October 20, 2017 |
| Days to Decision | 228 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DRC — Trocar |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1390 |