Submission Details
| 510(k) Number | K240997 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2024 |
| Decision Date | November 06, 2024 |
| Days to Decision | 209 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K240997 is an FDA 510(k) clearance for the Hi-Torque Command 14 ST Guide Wire and Hi-Torque Command 14 MT Guide Wire, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Abbott Medical (S,Mta Clara, US). The FDA issued a Cleared decision on November 6, 2024, 209 days after receiving the submission on April 11, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
| 510(k) Number | K240997 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 11, 2024 |
| Decision Date | November 06, 2024 |
| Days to Decision | 209 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 |