Steerant Super Stiff Guidewire
FDA 510(k) K232570 · Medtronic Vascular
510(k) numberK232570
Submission
- Device name
- Steerant Super Stiff Guidewire
- Applicant
- Medtronic Vascular
Santa Rosa, CA, US - Received
- August 24, 2023
- Decision date
- October 24, 2023
- 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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| 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 |
|---|---|---|
| K232190 | 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide CatheterDQY · Special | 08/22/2023SE |
| K230156 | 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F…DQY · Special | 06/30/2023SE |
| K220773 | Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special | 04/13/2022SE |
| K192296 | Medtronic 6F Taiga Guiding CatheterDQY · Special | 09/20/2019SE |
| K182957 | Heli-FX EndoAnchor SystemOTD · Special | 11/21/2018SE |
| K173515 | Admiral XtremeLIT · Traditional | 04/12/2018SE |
| K171866 | Sentrant Introducer Sheath with Hydrophilic CoatingDYB · Special | 12/20/2017SE |
| K170191 | SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision SystemMCW · Special | 06/16/2017SE |
| K171427 | Heli-FX Applier, Heli-FX Guide, Ancillary EndoAnchor CassetteOTD · Special | 06/13/2017SE |
| K162097 | InTRAkitDYB · Traditional | 11/17/2016SE |
Questions and answers
When was Steerant Super Stiff Guidewire cleared by the FDA?
Steerant Super Stiff Guidewire (K232570) received a 510(k) decision of Substantially Equivalent on October 24, 2023, 61 days after the submission was received.
What is the product code of K232570?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.