Home › Device types › OEX
Cardiovascular Catheter Sheath Introducer Kit
FDA product code OEX · Class 2 · Cardiovascular
83
Registered devices
17
Adverse events
2
Recalls
0
510(k) clearances
Devices with this code
Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Prelude IDeal™ Hydrophilic Sheath — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Prelude IDeal™ Hydrophilic Sheath — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Prelude® — Merit Medical Systems, Inc.Prelude IDeal™ Hydrophilic Sheath — Merit Medical Systems, Inc.Prelude IDeal™ Hydrophilic Sheath — Merit Medical Systems, Inc.Prelude IDeal™ Hydrophilic Sheath — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2009-03-16 | Spectranetics Corporation | Catheter outer jacket may split during use. |
| 2008-10-15 | Spectranetics Corporation | Catheter pouch was mislabeled with the wrong size. |
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