K182918 is an FDA 510(k) clearance for the Ballast 088 Long Sheath. This device is classified as a Catheter, Percutaneous (Class II - Special Controls, product code DQY).
Submitted by Balt USA, LLC (Irvine, US). The FDA issued a Cleared decision on March 21, 2019, 153 days after receiving the submission on October 19, 2018.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K182918 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 19, 2018 |
| Decision Date | March 21, 2019 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQY - Catheter, Percutaneous |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |