Company
Boston Scientific Cork, Ltd.
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
41recalls (41 in 12 months)
41recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KRA | Catheter, Continuous Flush | 41 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| 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 |