Panels › Cardiovascular › Product code MOF · Class 2
Guide, Wire, Catheter, Neurovasculature
Regulation 870.1330
12510(k)s in 12 months (45 all time)
0recalls in 12 months (2 all time)
2recalls that name a 510(k)
Top companies in MOF
| Company | 510(k)s | Recalls |
|---|---|---|
| Asahi Intecc Co., Ltd. | 10 | 0 |
| Scientia Vascular | 9 | 0 |
| MicroVention, Inc. | 6 | 1 |
| Arbor Endovascular, LLC | 5 | 0 |
| Rapid Medical Ltd. | 3 | 0 |
| Stryker Neurovascular | 1 | 1 |
| Artiria Medical SA | 1 | 0 |
| Balt USA, LLC | 1 | 0 |
| Codman & Shurtleff, Inc. | 1 | 0 |
| Enlight Medical Technologies (Shenzhen) Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2024 | Stryker Neurovascular The Synchro SELECT Guidewires are a steerable guidewire family with a shapeable
tip and are available in straight and pre-shaped versions. The outside diameters of the
guidewires are 0.014in. The guid Open, Classified |
MOF | K202522 |
| Aug 7, 2017 | Microvention, Inc. MicroVention Terumo Traxcess 7 Mini Guidewire with Hydrophilic Coating, Ref GW0721006M, 1 guidewire per package, sterile, RX. Terminated |
MOF | K161803 |
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