Panels › Cardiovascular › Product code OEX · Class 2
Cardiovascular Catheter Sheath Introducer Kit
Regulation 870.1340
0510(k)s in 12 months (0 all time)
0recalls in 12 months (2 all time)
0recalls that name a 510(k)
Top companies in OEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Spectranetics Corporation | 0 | 2 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 1, 2009 | Spectranetics Corporation Spectranetics SLS II Laser Sheath Kit, 14F, REF 500-012, Individually packaged catheter introducer. Terminated |
OEX | None listed |
| Jan 30, 2009 | Spectranetics Corporation Spectranetics SLS II 14Fr. Laser Sheath Kit, REF 500-012, Sterile EO, individually packaged, Lot number 080314B, Spectranetics, 96 Talamine Court, Colorado Springs, Colorado 80907.
A catheter introdu Terminated |
OEX | None listed |
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