Panels › Cardiovascular › Product code KRA · Class 2
Catheter, Continuous Flush
Regulation 870.1210
5510(k)s in 12 months (177 all time)
41recalls in 12 months (137 all time)
135recalls that name a 510(k)
Top companies in KRA
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130;
Material Number: M001195940 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130;
Material Number: M001195910 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155;
Material Number: M001195850 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130;
Material Number: M001195840 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130;
Material Number: M001195810 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155;
Material Number: M001195750 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130;
Material Number: M001195740 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155;
Material Number: M001195720 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130;
Material Number: M001195710 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130;
Material Number: M001195670 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130;
Material Number: M001195660 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155;
Material Number: M001195650 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130;
Material Number: M001195640 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155;
Material Number: M001195620 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130;
Material Number: M001195610 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155;
Material Number: M001195510 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130;
Material Number: M001195500 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155;
Material Number: M001195480 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130;
Material Number: M001195470 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155;
Material Number: M001195450 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130;
Material Number: M001195440 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105;
Material Number: M001195430 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155;
Material Number: M001195420 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130;
Material Number: M001195410 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105;
Material Number: M001195400 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155;
Material Number: M001195350 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130;
Material Number: M001195340 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155;
Material Number: M001195330 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130;
Material Number: M001195320 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155;
Material Number: M001195310 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130;
Material Number: M001195300 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105;
Material Number: M001195290 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155;
Material Number: M001195280 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130;
Material Number: M001195270 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105;
Material Number: M001195260 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155;
Material Number: M001195250 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130;
Material Number: M001195240 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105;
Material Number: M001195230 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155;
Material Number: M001195220 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130;
Material Number: M001195210 Open, Classified |
KRA | K163701 |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105;
Material Number: M001195200 Open, Classified |
KRA | K163701 |
| Feb 7, 2024 | Angiodynamics, Inc. PulseSpray Infusion System devices including: PULSE SPRAY 5F/135/20, UPN: H787125004045, REF: 12500404; Pulse Spray 3Fx135x20, UPN: H787125004155, REF: 12500415; and PULSE SPRAY 5F/45/10, UPN: H78712 Open, Classified |
KRA | K163356 |
| Jan 2, 2024 | Merit Medical Systems, Inc. Merit Maestro Microcatheter, Reference Numbers: 28MC2111045/B,
28MC21110ST/B,
28MC2113045/B,
28MC21130SN/CNB,
28MC21130ST/B,
28MC2115045/B,
28MC2115045/C,
28MC21150SN/B,
28MC21150ST/B,
28MC2411045/D, Open, Classified |
KRA | K172081 |
| Jun 30, 2022 | Micro Therapeutics, Inc. Echelon -14 Micro Catheter, REF: 105-5092-150, sterile EO, Rx Only Open, Classified |
KRA | K030688 K093750 |
| Jun 30, 2022 | Micro Therapeutics, Inc. Echelon -14, 45 Tip Shape, REF 145-5092150, sterile EO, Rx Only Open, Classified |
KRA | K030688 K093750 |
| Nov 3, 2020 | Boston Scientific Corporation EKOS Control System (CU) 4.0. UPN 600-40500
The EkoSonic MACH4 Endovascular (EKOS) System consists of a single use Infusion Catheter and Ultrasonic Core, and a reusable Control Unit 4.0. The device Open, Classified |
KRA | K183361 |
| Dec 9, 2019 | Cook Inc. CrossCath Support Catheter, RPN CXC3.4-2.2-18-150-P-NS-0, Order Number G51577 For diagnostic and interventional vascular procedures. Terminated |
KRA | K161801 |
| Dec 9, 2019 | Cook Inc. CrossCath Support Catheter, RPN CXC3.4-2.2-18-135-P-NS-0, Order Number G51583 For diagnostic and interventional vascular procedures. Terminated |
KRA | K161801 |
| Dec 9, 2019 | Cook Inc. CrossCath Support Catheter, RPN CXC3.4-2.2-18-90-P-NS-0, Order Number G51575 For diagnostic and interventional vascular procedures. Terminated |
KRA | K161801 |
| Dec 9, 2019 | Cook Inc. CrossCath Support Catheter, RPN CXC3.0-1.9-14-90-P-NS-0, Order Number G51572 For diagnostic and interventional vascular procedures. Terminated |
KRA | K161801 |
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