K191687 is an FDA 510(k) clearance for the pORTAL Steerable Hydrophilic Guidewire and pORTAL EXT Extension Wire. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Phenox Limited (Galway, IE). The FDA issued a Cleared decision on October 9, 2019, 107 days after receiving the submission on June 24, 2019.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K191687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 2019 |
| Decision Date | October 09, 2019 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |