R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
FDA 510(k) K212167 · Vascular Solutions, LLC
510(k) numberK212167
Submission
- Device name
- R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire
- Applicant
- Vascular Solutions, LLC
Minneapolis, MN, US - Received
- July 12, 2021
- Decision date
- February 9, 2022
- 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
Other 510(k)s with product code DQX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon…LOX · Traditional | 05/31/2024SE |
| K230637 | Wattson temporary pacing guidewire (2250)DQX · Traditional | 05/05/2023SE |
| K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272)…DQY · Special | 08/18/2022SE |
| K221470 | Langston dual lumen catheterDQO · Special | 06/17/2022SE |
| K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold…DQY · Traditional | 02/09/2022SE |
| K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheterDQY · Traditional | 04/30/2021SE |
| K193119 | Twin-Pass Dual Access CatheterDQY · Traditional | 06/29/2020SE |
| K200720 | D-Stat Radial Topical HemostatQSX · Special | 06/26/2020SE |
| K192454 | Wattson Temporary Pacing GuidewireDQX · Traditional | 01/15/2020SE |
| K191560 | Turnpike Catheter; Turnpike Spiral Catheter; Turnpike Gold Catheter; Turnpike LP CatheterDQY · Traditional | 08/09/2019SE |
Questions and answers
When was R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire cleared by the FDA?
R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire (K212167) received a 510(k) decision of Substantially Equivalent on February 9, 2022, 212 days after the submission was received.
What is the product code of K212167?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.