Panels › Cardiovascular › Product code DXE · Class 2
Catheter, Embolectomy
Regulation 870.5150
0510(k)s in 12 months (74 all time)
2recalls in 12 months (58 all time)
56recalls that name a 510(k)
Top companies in DXE
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 4, 2006 | Possis Medical, Inc AngioJet XMI Rapid Exchange +, 4F, 135 cm. Contents: One (1) Thrombectomy Catheter for Peripheral Use. Sterilized with Ethylene Oxide. Single Use Only. Manufactured and Distributed by: Possis M Terminated |
DXE | K042874 |
| May 13, 2005 | Arrow International Inc The Arrow Trerotola Percutaneous Thrombolytic Device (Product Codes: PT-65709-WC, PT-65709-W, PT-65709-HFWC, and PT-12709-WC) consists of a catheter with an expandable fragmentation basket attached t Terminated |
DXE | K011056 |
| Feb 24, 2005 | Lemaitre Vascular, Inc. LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml , Length 80 cm Latex
Product Number: 1601-28 Terminated |
DXE | None listed |
| Feb 24, 2005 | Lemaitre Vascular, Inc. LeMaitre Embolectomy Catheter 5F Single Lumen, Balloon Volume 1.5 ml, Length 80 cm, Latex
Model: 1601-58 Terminated |
DXE | K992368 |
| Feb 24, 2005 | Lemaitre Vascular, Inc. LeMaitre Embolectomy Catheter 4F Single Lumen, Balloon Volume 0.75 ml, Length 80 cm, Latex
Model: 1601-48 Terminated |
DXE | None listed |
| Feb 24, 2005 | Lemaitre Vascular, Inc. LeMaitre Embolectomy Catheter 3F Single Lumen, Balloon volume 0.2ml, Length 80 cm, Latex
Model: 1601-38 Terminated |
DXE | K992368 |
| Feb 24, 2005 | Lemaitre Vascular, Inc. LeMaitre Embolectomy Catheter 2F Single Lumen, Balloon Volume 0.05 ml, Length 60 cm. Latex
Model: 1601-26 Terminated |
DXE | K992368 |
| Jul 20, 2004 | Vascular Solutions, Inc. The Pronto Extraction Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the arterial system. Terminated |
DXE | K032763 |
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