K210328 is an FDA 510(k) clearance for the SafeSept Blunt Needle. 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 March 5, 2021, 29 days after receiving the submission on February 4, 2021.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1390.
| 510(k) Number | K210328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 04, 2021 |
| Decision Date | March 05, 2021 |
| Days to Decision | 29 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 |