510(k) K163701 ยท KRA Catheter, Continuous Flush
Direxion and Direxion HI-FLO Torqueable Microcatheters
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, May 16, 2017 |
| Received | Dec 29, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163701
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/105;
Material Number: M001195200 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/130;
Material Number: M001195210 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/1RO/155;
Material Number: M001195220 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105;
Material Number: M001195230 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130;
Material Number: M001195240 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/155;
Material Number: M001195250 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105;
Material Number: M001195260 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/130;
Material Number: M001195270 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155;
Material Number: M001195280 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105;
Material Number: M001195290 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130;
Material Number: M001195300 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/155;
Material Number: M001195310 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/130;
Material Number: M001195320 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/STRAIGHT/2RO/155;
Material Number: M001195330 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130;
Material Number: M001195340 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155;
Material Number: M001195350 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/105;
Material Number: M001195400 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/130;
Material Number: M001195410 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/STRAIGHT/1RO/155;
Material Number: M001195420 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/105;
Material Number: M001195430 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130;
Material Number: M001195440 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155;
Material Number: M001195450 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/130;
Material Number: M001195470 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/J/1RO/155;
Material Number: M001195480 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/130;
Material Number: M001195500 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/SINGLE/027/SWAN/1RO/155;
Material Number: M001195510 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/130;
Material Number: M001195610 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/1RO/155;
Material Number: M001195620 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/130;
Material Number: M001195640 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/1RO/155;
Material Number: M001195650 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/STRAIGHT/2RO/130;
Material Number: M001195660 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/021/BERN/2RO/130;
Material Number: M001195670 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/130;
Material Number: M001195710 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/STRAIGHT/1RO/155;
Material Number: M001195720 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/130;
Material Number: M001195740 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155;
Material Number: M001195750 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130;
Material Number: M001195810 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130;
Material Number: M001195840 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/155;
Material Number: M001195850 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130;
Material Number: M001195910 Open, Classified |
KRA | None listed |
| Oct 22, 2026 | Boston Scientific Cork, Ltd. Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130;
Material Number: M001195940 Open, Classified |
KRA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.