Device type
Catheter, Continuous Flush
Product code KRA · Class II · 21 CFR 870.1210 · Cardiovascular
Recent 510(k)s
Sep 21, 2026
K253509
TriSalus TriNav Advance Infusion System
Trisalus Life Sciences
- KRA
- Class II
Sep 11, 2026
K254051
Extroducer Infusion Catheter System
SmartWise Sweden AB
- KRA
- Class II
Recent recalls
Oct 28, 2026
Z-0243-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/130; Material Number: M001195440
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0258-2027
Direxion Torqueable Microcatheter, NGMC/FATHOM/027/BERN/1RO/155; Material Number: M001195750
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0231-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/155; Material Number: M001195280
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0229-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/J/1RO/105; Material Number: M001195260
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0260-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/BERN/1RO/130; Material Number: M001195840
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0227-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/130; Material Number: M001195240
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0237-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/130; Material Number: M001195340
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0259-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/021/STRAIGHT/1RO/130; Material Number: M001195810
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0233-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/130; Material Number: M001195300
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0226-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/1RO/105; Material Number: M001195230
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0244-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/027/BERN/1RO/155; Material Number: M001195450
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0262-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/STRAIGHT/1RO/130; Material Number: M001195910
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0263-2027
Direxion Torqueable Microcatheter, NGMC/TRANSEND/027/BERN/1RO/130; Material Number: M001195940
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0238-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/BERN/2RO/155; Material Number: M001195350
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing
Oct 28, 2026
Z-0232-2027
Direxion Torqueable Microcatheter, NGMC/SINGLE/021/SWAN/1RO/105; Material Number: M001195290
Boston Scientific Cork, Ltd.
- KRA
- Class II
- Ongoing