HI-TORQUE TurnTrac Guide Wire Family
FDA 510(k) K173795 · Abbott Vascular
510(k) numberK173795
Submission
- Device name
- HI-TORQUE TurnTrac Guide Wire Family
- Applicant
- Abbott Vascular
Santa Clara, CA, US - Received
- December 14, 2017
- Decision date
- January 12, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K253667 | Accoat Guide WireDQX · Traditional | Sp Medical A/S | 07/14/2026SE |
| K261640 | Merit MAK Nitinol/Gold-Tungsten Guide WireDQX · Special | Merit Medical Ireland , Ltd. | 07/13/2026SE |
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| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
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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 |
| K252674 | Solo Pace Fusion System (SOLOFUSE1)DQX · Traditional | Solo Pace, Inc. | 01/09/2026SE |
More from Solo Pace, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K220634 | NC TREK NEO Coronary Dilatation CatheterLOX · Traditional | 06/30/2022SE |
| K221057 | Viatrac 14 Plus Peripheral Dilatation CatheterLIT · Special | 05/05/2022SE |
| 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 |
| K172394 | Steerable Guide CatheterDRA · Special | 09/06/2017SE |
| K172073 | Hi-Torque Command 18 Guide WireDQX · Special | 08/25/2017SE |
| K161985 | Steerable Guide CatheterDRA · Special | 08/07/2016SE |
Questions and answers
When was HI-TORQUE TurnTrac Guide Wire Family cleared by the FDA?
HI-TORQUE TurnTrac Guide Wire Family (K173795) received a 510(k) decision of Substantially Equivalent on January 12, 2018, 29 days after the submission was received.
What is the product code of K173795?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.