Minneapolis, MN, US · 10 510(k) clearances · 2 PMAs · 5 recalls (5 Class I)
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| DQY | Catheter, Percutaneous | Class II | Cardiovascular | 4 | 2022-08-18 |
| DQX | Wire, Guide, Catheter | Class II | Cardiovascular | 3 | 2023-05-05 |
| LOX | Catheters, Transluminal Coronary Angioplasty, Percutaneous | Class II | Cardiovascular | 1 | 2024-05-31 |
| DQO | Catheter, Intravascular, Diagnostic | Class II | Cardiovascular | 1 | 2022-06-17 |
| QSX | Hemostatic Wound Dressing With Thrombin Or Other Biologics | Unclassified | Unknown | 1 | 2020-06-26 |
| Date | PMA # | Trade name | Type | Code | Device name | Specialty |
|---|---|---|---|---|---|---|
| 2022-11-04 | P990037-S036 | Duett Sealing Device (D-Stat Flowable) | Normal 180 Day Track | MGB | Device, Hemostasis, Vascular | Unknown |
| 2021-07-13 | P990037-S035 | Duett Sealing Device | 30-Day Notice | MGB | Device, Hemostasis, Vascular | Unknown |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2020-08-31 | Class I | Terminated | Z-0113-2021 | Langston Dual Lumen Catheter. | — | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| 2020-08-31 | Class I | Terminated | Z-0112-2021 | Langston Dual Lumen Catheter. | — | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| 2020-08-31 | Class I | Terminated | Z-0111-2021 | Langston Dual Lumen Catheter. | — | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| 2020-08-31 | Class I | Terminated | Z-0110-2021 | Langston Dual Lumen Catheter | — | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| 2020-03-16 | Class I | Terminated | Z-1747-2020 | Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies | — | The inner lumen of the Langston catheter may separate from the hub during pressure injection. |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2024-05-31 | K233729 | Ringer perfusion balloon catheter, 2.00 x 20mm (5881); Ringer perfusion balloon catheter, 2.50 x 20mm (5882); Ringer perfusion balloon catheter, 2.50 x 30mm (5883); Ringer perfusion balloon catheter, 3.00 x 20mm (5884); Ringer perfusion balloon catheter, 3.00 x 30mm (5885); Ringer perfusion balloon catheter, 3.50 x 20mm (5886); Ringer perfusion balloon catheter, 3.50 x 30mm (5887); Ringer perfusion balloon catheter, 4.00 x 20mm (5888); Ringer perfusion balloon catheter, 4.00 x 30mm (58 | LOX | Class II | Cardiovascular |
| 2023-05-05 | K230637 | Wattson temporary pacing guidewire (2250) | DQX | Class II | Cardiovascular |
| 2022-08-18 | K220647 | GuideLiner Coast, 5.5F (5270); GuideLiner Coast, 6F (5271); GuideLiner Coast, 7F (5272); GuideLiner Coast, 8F (5273) | DQY | Class II | Cardiovascular |
| 2022-06-17 | K221470 | Langston dual lumen catheter | DQO | Class II | Cardiovascular |
| 2022-02-09 | K212211 | Turnpike catheter, Turnpike Spiral catheter, Turnpike LP catheter, Turnpike Gold catheter, GuideLiner V3 catheter, TrapLiner catheter | DQY | Class II | Cardiovascular |
| 2022-02-09 | K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewire | DQX | Class II | Cardiovascular |
| 2021-04-30 | K210647 | SuperCross microcatheter, SuperCross FT microcatheter, SuperCross AT microcatheter | DQY | Class II | Cardiovascular |
| 2020-06-29 | K193119 | Twin-Pass Dual Access Catheter | DQY | Class II | Cardiovascular |
| 2020-06-26 | K200720 | D-Stat Radial Topical Hemostat | QSX | Unclassified | Unknown |
| 2020-01-15 | K192454 | Wattson Temporary Pacing Guidewire | DQX | Class II | Cardiovascular |