Product code NJE ยท Class f
Intracranial Neurovascular Stent
0510(k)s in 12 months (0 all time)
0recalls in 12 months (7 all time)
0recalls that name a 510(k)
Top companies in NJE
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corporation | 0 | 3 |
| Stryker Neurovascular | 0 | 3 |
| Codman & Shurtleff, Inc. | 0 | 1 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 5, 2018 | Stryker Neurovascular Wingspan Stent System, Rx Only, Sterile EO, Catalog #: M003WE0250090, M003WE0300090, M003WE0350090, M003WE0400090, M003WE0450090,
M003WE0250150, M003WE0300150, M003WE0350150, M003WE0400150, M003WE0450 Terminated |
NJE | None listed |
| Dec 16, 2014 | Stryker Neurovascular Gateway OTW 2.75mm x 9mm;
The Gateway PTA balloon catheter is indicated for balloon dilation of the stenotic portion of intracranial arteries for the purpose of improving intracranial perfusion. Terminated |
NJE | None listed |
| Jul 25, 2013 | Stryker Neurovascular Stryker brand Neuroform 3 Microdelivery Stent System, 4.5 mm X 20 mm, REF Catalog Number: E345020, Model/Product Number: M003450200, Product is manufactured by Boston Scientific Corporation, Fremont, Terminated |
NJE | None listed |
| Jun 29, 2011 | Codman & Shurtleff, Inc. CODMAN ENTERPRISE Vascular Reconstruction Device and Delivery System 4.5mm x 28mm
Product code: ENF452812 Terminated |
NJE | None listed |
| Dec 16, 2010 | Boston Scientific Corporation Wingspan Stent System, Model Number M003WE0300150, Manufactured by Boston Scientific, Fremont, CA
Indicated for use in improving cerebral artery lumen diameter in patients with intracranial atheroscl Terminated |
NJE | None listed |
| Nov 26, 2010 | Boston Scientific Corporation Neuroform 3 Microdelivery Stent System; Distributed and manufactured by: Boston Scientific Corporation, Fremont, CA Terminated |
NJE | None listed |
| Sep 9, 2009 | Boston Scientific Corporation Neuroform 3 Microdelivery Stent System, Model Number M003E3400300, Catalog model number and product upn number M00490310, manufactured by Boston Scientific Corporation, Fremont, CA. Terminated |
NJE | None listed |
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