Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)
Maquet Critical Care AB · Gastroenterology, Urology
Open FDA's page for this record- Third party flag
- N
- City
- Solna
- Advisory committee description
- Gastroenterology, Urology
- Address 1
- Röntgenvägen 2 Se-171 54
- Statement or summary
- Summary
- Product code
- PIF
- Applicant
- Maquet Critical Care AB
- Decision date
- 2026-08-26
- Decision code
- SESE
- Country code
- SE
- Advisory committee
- GU
- Contact
- Jerker Åberg
- K number
- K253715
- Date received
- 2025-11-24
- Review advisory committee
- GU
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Device name
Edi Catheter ENFit 6Fr/48 cm (6893166); Edi Catheter ENFit 6Fr/49cm (6893273); Edi Catheter ENFit 6Fr/50cm (6893274); Edi Catheter ENFit 8Fr/50cm (6893275); Edi Catheter ENFit 8Fr/100cm (6893276); Edi Catheter ENFit 8Fr/125cm (6893277); Edi Catheter ENFit 12Fr/125cm (6893278); Edi Catheter ENFit 16Fr/125cm (6893279)
- Harmonized identifiers (openFDA)
- Device name
- Gastrointestinal Tubes With Enteral Specific Connectors
- Medical specialty description
- Gastroenterology, Urology
- Regulation number
- 876.5980
- Device class
- 2
- Registration number
- 1417592, 8030107, 3005580113, 9612030, 8022978, 1000121056, 1722139, 3010017366, 3031190571, 1058397, 3015462350, 1000317571, 1048735, 3041276591, 3014016859, 3017509841, 3007289408, 3004784537, 3005674464, 3027341532, 3008058400, 3010273872, 3014662855, 3008311916, 3009988302, 3018366470, 9618003, 3011270181, 8010042, 3014615028, 9610849, 1419562, 3001124136, 3005099803, 3017081712, 1225687, 3008044552, 3008448733, 3012881740, 3007766601 +49 more
- FEI number
- 1417592, 7682, 3005580113, 1000121056, 3010017366, 3031190571, 3003282547, 3015462350, 1000317571, 1048735, 3002806934, 3041276591, 3014016859, 1000160458, 3017509841, 3007289408, 3004784537, 3002806565, 3005674464, 3027341532, 3008058400, 3010273872, 3007596547, 3014662855, 3008311916, 3009988302, 3003264198, 3018366470, 3011270181, 3014615028, 1419562, 3002808128, 1000158532, 3001124136, 3005099803, 3005596530, 3017081712, 3008044552, 3008448733, 3002807391 +49 more