Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX)
FDA 510(k) K961917 · Medtronics Interventional Vascular
510(k) numberK961917
Submission
- Device name
- Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX)
- Applicant
- Medtronics Interventional Vascular
San Diego, CA, US - Received
- May 17, 1996
- Decision date
- November 20, 1996
- 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 |
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| 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 |
|---|---|---|
| K990707 | Medtronic 5F & 9F Zuma Guiding CathetersDQY · Special | 03/22/1999SE |
| K980973 | Medtronic Angiographic CatheterDQO · Traditional | 12/10/1998SE |
| K982883 | Medtronic 7F and 8F Zuma Guiding CatheterDQY · Special | 09/04/1998SE |
| K981198 | Medtronic Zuma Guiding CatheterDQY · Traditional | 08/07/1998SE |
| K972944 | Medtronic Mustang Super Floppy Guide Wire/Floppy Guide Wire/Intermediate Guide…DQX · Traditional | 11/03/1997SE |
| K960983 | Medtronic Everst 30 Inflation Device/Survival KitMAV · Traditional | 05/30/1996SE |
| K955651 | Medtronic Sherpa Guiding CatheterDQY · Traditional | 01/22/1996SE |
| K950490 | Medtronic GC IV Coronary Guiding CatheterDQY · Traditional | 11/21/1995SE |
| K950179 | Medtronic(R) GC III Coronary Guiding CatheterDQY · Traditional | 07/25/1995SE |
| K950026 | Medtronic(R) 8.2 French Sherpa(R) Super Peak Flow(Tm) Coronary Guiding CatheterDQY · Traditional | 04/05/1995SE |
Questions and answers
When was Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX) cleared by the FDA?
Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX) (K961917) received a 510(k) decision of Substantially Equivalent on November 20, 1996, 187 days after the submission was received.
What is the product code of K961917?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.