Extroducer Infusion Catheter System
SmartWise Sweden AB · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Tullinge
- Advisory committee description
- Cardiovascular
- Address 1
- Alfred Nobels Allé 150
- Statement or summary
- Summary
- Product code
- KRA
- Zip code
- 146 48
- Applicant
- SmartWise Sweden AB
- Decision date
- 2026-09-11
- Decision code
- SESE
- Country code
- SE
- Device name
- Extroducer Infusion Catheter System
- Advisory committee
- CV
- Contact
- Kamran Kaviani
- K number
- K254051
- Date received
- 2025-12-17
- Review advisory committee
- CV
- Postal code
- 146 48
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Catheter, Continuous Flush
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.1210
- Device class
- 2
- Registration number
- 3021067373, 3009380063, 3017210488, 3020256033, 3039020025, 3010220595, 3010047454, 1000121056, 3010041511, 3004111573, 1644312, 1820334, 3013391155, 3008514120, 3010421104, 3014758755, 3030733800, 1718873, 3012497308, 1048735, 3040099838, 3015309643, 2134265, 3010079067, 9617601, 1319211, 8020616, 3009756153, 1713468, 1220452, 1018233, 3004142795, 3005941719, 3010273872, 3040801290, 3033589330, 3015225571, 1724474, 1000393132, 3031823122 +109 more
- FEI number
- 3021067373, 3009380063, 3017210488, 3020256033, 3039020025, 3001237758, 3003081151, 3010220595, 3010047454, 1000121056, 3010041511, 3004111573, 3002827704, 1820334, 3013391155, 3008514120, 3003807466, 3010421104, 3014758755, 3030733800, 1718873, 3012497308, 1048735, 3040099838, 3015309643, 3010079067, 1319211, 3002806565, 3009756153, 1713468, 1220452, 2828, 3002806476, 1018233, 3004142795, 3010273872, 3040801290, 3033589330, 3015225571, 1000393132 +109 more