Micrus One 2 One Guidewire and Soft Guidewire
FDA 510(k) K090274 · Micrus Endovascular Corporation
510(k) numberK090274
Submission
- Device name
- Micrus One 2 One Guidewire and Soft Guidewire
- Applicant
- Micrus Endovascular Corporation
San Jose, CA, US - Received
- February 4, 2009
- Decision date
- March 3, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K103780 | Micrus Ascent Occlusion Balloon Catheter 4X7 MM; Micrus Ascent Occlusion Balloon…MJN · Special | 01/26/2011SE |
| K102818 | Micrus One 2 One Guidewire, Micrus One 2 One Soft GuidewireDQX · Special | 12/03/2010SE |
| K092702 | Micrus Microcatheter, Model Courier 270DQO · Special | 11/20/2009SE |
| K091504 | Micrus Ascent Occlusion Balloon Catheter 4X7MM,6X9MM, Micrus Summit Occlusion Balloon…MJN · Special | 06/19/2009SE |
| K083922 | Micrus Microcatheter, Courier Flex, Model MSF 170000-00DQO · Special | 05/06/2009SE |
| K083646 | Micrus Microcoli System, Deltaplush, Models CPL, DPLHCG · Special | 01/02/2009SE |
| K082739 | Micrus Microcoil Delivery SystemHCG · Special | 10/17/2008SE |
| K080861 | Micrus Ascent Occlusion Balloon CatheterMJN · Traditional | 08/27/2008SE |
| K080379 | Micrus Microcoil System, Deltapaq 10 Stretch ResistantHCG · Traditional | 06/30/2008SE |
| K080437 | Micrus Microcoil System, Deltapaq 10 Cerecyte, Model CDFHCG · Traditional | 05/08/2008SE |
Questions and answers
When was Micrus One 2 One Guidewire and Soft Guidewire cleared by the FDA?
Micrus One 2 One Guidewire and Soft Guidewire (K090274) received a 510(k) decision of Substantially Equivalent on March 3, 2009, 27 days after the submission was received.
What is the product code of K090274?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.