ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
FDA 510(k) K163426 · Asahi Intecc Co., Ltd.
510(k) numberK163426
Submission
- Device name
- ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension
- Applicant
- Asahi Intecc Co., Ltd.
Hagoya-Shi, JP - Received
- December 6, 2016
- Decision date
- April 3, 2017
- 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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| 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.
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| K251560 | FUBUKI XF-R Neurovascular Long SheathQJP · Special | 06/20/2025SE |
| K251240 | Branchor X Balloon Guide CatheterQJP · Traditional | 06/20/2025SE |
| K243383 | CHIKAI Nexus 014MOF · Traditional | 04/21/2025SE |
| K243733 | SION blue PLUSDQX · Special | 04/02/2025SE |
| K241962 | CrossloopDQX · Traditional | 03/27/2025SE |
| K242597 | CROSSLEAD 0.018inchDQX · Special | 03/05/2025SE |
| K241702 | CROSSLEAD 0.014inchDQX · Special | 02/06/2025SE |
| K241801 | Tornus ESFGE · Traditional | 12/17/2024SE |
Questions and answers
When was ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension cleared by the FDA?
ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension (K163426) received a 510(k) decision of Substantially Equivalent on April 3, 2017, 118 days after the submission was received.
What is the product code of K163426?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.