Product code MOF
- Device name
- Guide, Wire, Catheter, Neurovasculature
- Medical specialty
- Cardiovascular
- Device class
- 2
- Regulation number
- 870.1330
- Review panel
- NE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Ineligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253579 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, Inc. | 2026-04-29 |
| K252317 | Zenith Micro Guidewire | Suzhou Zenith Vascular SciTech Limited | 2026-04-16 |
| K260537 | Willow 24 Guidewire | Arbor Endovascular, LLC | 2026-03-19 |
| K252122 | DCwire Micro-guidewire | Shanghai Achieva Medical Suzhou Co., Ltd. | 2026-03-16 |
| K260130 | Willow 18 Guidewire | Arbor Endovascular, LLC | 2026-02-13 |
| K252011 | CHIKAI Nexus petit | Asahi Intecc Co., Ltd. | 2026-02-02 |
| K253168 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025-11-26 |
| K244061 | X-Wire Guidewire | Imperative Care, Inc. | 2025-08-26 |
| K243756 | 0.014” Willow Guidewire | Arbor Endovascular, LLC | 2025-07-17 |
| K243383 | CHIKAI Nexus 014 | Asahi Intecc Co., Ltd. | 2025-04-21 |
| K243938 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Zoom Wire 14 Guidewire; Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2025-04-01 |
| K240871 | Synxess Neurovascular Guidewire | Enlight Medical Technologies (Shenzhen) Co., Ltd. | 2024-11-18 |
| K233791 | Drivewire 24 Guidewire | Rapid-Medical , Ltd. | 2024-07-11 |
| K231954 | Aristotle 18 Guidewire; Aristotle 24 Guidewire | Scientia Vascular, Inc. | 2023-08-01 |
| K222690 | SmartGUIDE deflectable hydrophilic guidewire | Artiria Medical SA | 2023-04-24 |
| K220398 | Aristotle 14 Guidewire; Aristotle 18 Guidewire; Aristotle 24 Guidewire; Volo 14 Guidewire; Zoom Wire 14 Guidewire | Scientia Vascular, LLC | 2023-03-10 |
| K222437 | Aristotle Colossus Guidewire | Scientia Vascular, Inc. | 2023-01-26 |
| K220934 | RADIFOCUS Torque Device | Terumo Medical Products (Hangzhou) Co., Ltd. | 2022-06-29 |
| K200374 | Columbus Guidewire | Rapid-Medical , Ltd. | 2020-12-14 |
| K202522 | Synchro SELECT Guidewire | Stryker Neurovascular | 2020-09-25 |
| K201487 | Traxcess 7 Mini Guidewire | MicroVention, Inc. | 2020-07-02 |
| K200547 | Traxcess 14 SELECT Guidewire | MicroVention, Inc. | 2020-04-16 |
| K191714 | ASAHI Neurovascular Guide Wire CHIKAI X 014 soft | Asahi Intecc Co., Ltd. | 2019-07-26 |
| K190843 | Synchro2 Support Guidewire | Stryker | 2019-05-01 |
| K183608 | Aristotle 18 Guidewire, 200cm, Soft Profile ; Aristotle 18 Guidewire, 200cm, Standard Profile ; Aristotle 18 Guidewire, 200cm, Support Profile | Scientia Vascular, LLC | 2019-03-22 |
| K183070 | ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010 | Asahi Intecc Co., Ltd. | 2019-01-29 |
| K182337 | HYBRID Guidewire | Balt USA, LLC | 2018-10-04 |
| K181828 | Volo 14 Guidewire, 200cm, Soft Profile, Volo 14 Guidewire, 200cm, Standard Profile, Volo 14 Guidewire, 300cm, Soft Profile, Volo 14 Guidewire, 300cm, Standard Profile | Scientia Vascular, LLC | 2018-08-07 |
| K171613 | ASAHI Neurovasulature Guide Wire: ASAHI CHIKAI black 18 soft tip | Asahi Intecc Co., Ltd. | 2017-07-01 |
| K163154 | Traxcess 7 Mini XSoft Guidewire | MicroVention, Inc. | 2016-12-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00763000518929 | X-Pedion | Micro Therapeutics, Inc. | 2024-10-21 |
| 00763000518912 | Mirage | Micro Therapeutics, Inc. | 2024-10-21 |
| 36927675513480 | RADIFOCUS | Terumo Medical Products (Hangzhou) Co., Ltd. | 2022-12-08 |
| 07613327508505 | Synchro SELECT | Stryker Corporation | 2020-10-20 |
| 07613327508574 | Synchro SELECT | Stryker Corporation | 2020-10-20 |
| 07613327508598 | Synchro SELECT | Stryker Corporation | 2020-10-20 |
| 07613327508604 | Synchro SELECT | Stryker Corporation | 2020-10-20 |
| 07613327508611 | Synchro SELECT | Stryker Corporation | 2020-10-20 |
| 07613327508642 | Synchro SELECT | Stryker Corporation | 2020-10-20 |
| 00763000294113 | X-Pedion | Micro Therapeutics, Inc. | 2020-07-31 |
| 00818075010110 | Aristotle | SCIENTIA VASCULAR LLC | 2020-02-24 |
| 00818075010103 | Aristotle | SCIENTIA VASCULAR LLC | 2020-02-24 |
| 00818075010097 | Aristotle | SCIENTIA VASCULAR LLC | 2020-02-24 |
| 07613327459630 | Synchro2 | Stryker Corporation | 2019-06-20 |
| 07613327459654 | Synchro2 | Stryker Corporation | 2019-06-20 |
| 00818053022814 | HYBRID Guidewire | BALT USA LLC | 2018-12-01 |
| 00818053022791 | HYBRID Guidewire | BALT USA LLC | 2018-12-01 |
| 00818053022777 | HYBRID Guidewire | BALT USA LLC | 2018-12-01 |
| 00818053022753 | HYBRID Guidewire | BALT USA LLC | 2018-12-01 |
| 00818053022739 | HYBRID Guidewire | BALT USA LLC | 2018-12-01 |
| 00816777025494 | Traxcess 7 Mini | Microvention, Inc. | 2018-08-07 |
| 00812636022260 | Traxcess SELECT | Microvention, Inc. | 2018-08-07 |
| B293VR014205G0 | Vi-Radius | MIVI NEUROVASCULAR | 2016-09-28 |
| 10886704029083 | AGILITY | Cerenovus, Inc. | 2016-06-30 |
| 10886704028406 | NEUROSCOUT | Medos International Sàrl | 2016-06-30 |
| 10886704029045 | AGILITY | Cerenovus, Inc. | 2016-06-30 |
| 10886704029052 | AGILITY | Cerenovus, Inc. | 2016-06-30 |
| 10886704028383 | NEUROSCOUT | Medos International Sàrl | 2016-06-30 |
| 10886704029076 | AGILITY | Cerenovus, Inc. | 2016-06-30 |
| 10886704029090 | AGILITY | Cerenovus, Inc. | 2016-06-30 |