Hi-Torque JET Guide Wire Family
FDA 510(k) K142415 · Abbott Vascular, Inc.
510(k) numberK142415
Submission
- Device name
- Hi-Torque JET Guide Wire Family
- Applicant
- Abbott Vascular, Inc.
Temecula, CA, US - Received
- August 28, 2014
- Decision date
- December 19, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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| K201834 | HI-TORQUE PROCEED Guide Wire FamilyDQX · Special | 07/30/2020SE |
| K200144 | HI-TORQUE Steelcore Bare Guide WireDQX · Traditional | 04/08/2020SE |
| K193126 | HI-TORQUE InfilTrac Guide Wire FamilyDQX · Special | 12/11/2019SE |
| K191173 | Emboshield NAV6 Embolic Protection System, Barewire Filter Delivery WiresNTE · Traditional | 07/25/2019SE |
| K180040 | NC TREK RX Coronary Dilatation Catheter; NC TREK OTW Coronary Dilatation Catheter…LOX · Special | 08/24/2018SE |
| K173795 | HI-TORQUE TurnTrac Guide Wire FamilyDQX · Special | 01/12/2018SE |
| K172394 | Steerable Guide CatheterDRA · Special | 09/06/2017SE |
| K172073 | Hi-Torque Command 18 Guide WireDQX · Special | 08/25/2017SE |
Questions and answers
When was Hi-Torque JET Guide Wire Family cleared by the FDA?
Hi-Torque JET Guide Wire Family (K142415) received a 510(k) decision of Substantially Equivalent on December 19, 2014, 113 days after the submission was received.
What is the product code of K142415?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.