K191502 is an FDA 510(k) clearance for the Heraeus Peripheral Guidewire. This device is classified as a Wire, Guide, Catheter (Class II - Special Controls, product code DQX).
Submitted by Heraeus Medical Components, LLC (Plymouth, US). The FDA issued a Cleared decision on November 26, 2019, 173 days after receiving the submission on June 6, 2019.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K191502 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 06, 2019 |
| Decision Date | November 26, 2019 |
| Days to Decision | 173 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DQX - Wire, Guide, Catheter |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1330 |