Medtronic Interventional Vascular Sherpa Guidewire
FDA 510(k) K925342 · Medtronics Interventional Vascular
510(k) numberK925342
Submission
- Device name
- Medtronic Interventional Vascular Sherpa Guidewire
- Applicant
- Medtronics Interventional Vascular
Danvers, MA, US - Received
- October 20, 1992
- Decision date
- May 6, 1993
- 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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| K251385 | InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire…DQX · Traditional | Merit Medical Ireland, Ltd. | 01/21/2026SE |
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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 |
| K961917 | Medtronic Mustang Steerable Guide Wire (M-45FR, M45FX)DQX · Traditional | 11/20/1996SE |
| 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 |
Questions and answers
When was Medtronic Interventional Vascular Sherpa Guidewire cleared by the FDA?
Medtronic Interventional Vascular Sherpa Guidewire (K925342) received a 510(k) decision of Substantially Equivalent on May 6, 1993, 198 days after the submission was received.
What is the product code of K925342?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.