HI-TORQUE PROCEED Guide Wire Family
FDA 510(k) K201834 · Abbott Vascular
510(k) numberK201834
Submission
- Device name
- HI-TORQUE PROCEED Guide Wire Family
- Applicant
- Abbott Vascular
Santa Clara, CA, US - Received
- July 2, 2020
- Decision date
- July 30, 2020
- 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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|---|---|---|---|
| K261281 | CROSSLEAD Standard 035 and CROSSLEAD Stiff 035DQX · Traditional | Filmecc Co., Ltd. | 09/03/2026SE |
| 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 |
| K254137 | InQwire Amplatz Guide WireDQX · Traditional | Merit Medical Ireland, Ltd. | 05/22/2026SE |
| K260544 | FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD…DQX · Special | FMD Co., Ltd. | 03/20/2026SE |
| K253746 | Enroute 0.014'' Transcarotid GuidewireDQX · Special | Lake Region Medical | 03/19/2026SE |
| K253262 | EmeryGlide (EG18008901)DQX · Special | Nano4imaging GmbH | 03/06/2026SE |
| K253847 | Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)DQX · Special | Merit Medical Ireland, Ltd. | 01/31/2026SE |
| 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 |
| 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 |
| K161985 | Steerable Guide CatheterDRA · Special | 08/07/2016SE |
Questions and answers
When was HI-TORQUE PROCEED Guide Wire Family cleared by the FDA?
HI-TORQUE PROCEED Guide Wire Family (K201834) received a 510(k) decision of Substantially Equivalent on July 30, 2020, 28 days after the submission was received.
What is the product code of K201834?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.