Submission Details
| 510(k) Number | K193126 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 12, 2019 |
| Decision Date | December 11, 2019 |
| Days to Decision | 29 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
HI-TORQUE InfilTrac Guide Wire Family
Dec 2019
Decision
29d
Days
Class 2
Risk
About This 510(k) Submission
K193126 is an FDA 510(k) clearance for the HI-TORQUE InfilTrac Guide Wire Family, a Wire, Guide, Catheter (Class II — Special Controls, product code DQX), submitted by Abbott Vascular (S,Mta Clara, US). The FDA issued a Cleared decision on December 11, 2019, 29 days after receiving the submission on November 12, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1330.
Device Classification
| Product Code | DQX — Wire, Guide, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1330 |
Manufacturer
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