HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
Eurosets S.R.L · Cardiovascular
Open FDA's page for this record- Third party flag
- N
- City
- Medolla
- Advisory committee description
- Cardiovascular
- Address 1
- Strada Statale 12, N°143
- Statement or summary
- Summary
- Product code
- DTZ
- Zip code
- 41036
- Applicant
- Eurosets S.R.L
- Decision date
- 2026-09-14
- Decision code
- SESE
- Country code
- IT
- Device name
- HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
- Advisory committee
- CV
- Contact
- Katia Vescovini
- K number
- K261438
- Date received
- 2026-04-30
- Review advisory committee
- CV
- Postal code
- 41036
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Oxygenator, Cardiopulmonary Bypass
- Medical specialty description
- Cardiovascular
- Regulation number
- 870.4350
- Device class
- 2
- Registration number
- 2184009, 3019807891, 3014990448, 3005941719, 3016746283, 1220648, 3015136750, 9680841, 2528981, 3011554160, 1218444, 8010762, 3009507273, 1643817, 3010163695, 3030125051, 3021599320, 2011171, 3002806603, 3008307705, 1928237, 3013267343, 9681834, 1124841, 9617601, 3044156918, 3002807090, 3003752502, 8010026, 2916596, 3010155661, 1319639, 1625519, 3045892899
- FEI number
- 3019807891, 3014990448, 3016746283, 1220648, 3015136750, 3009649876, 3006003617, 2528981, 3011554160, 1218444, 3009507273, 1643817, 3002534070, 3010163695, 3030125051, 3021599320, 2011171, 3002806603, 3008307705, 1928237, 3013267343, 3044156918, 3003752502, 3005426550, 3002807111, 3002808327, 1000116158, 2916596, 3010155661, 1000138054, 1625519, 3045892899, 3000204839, 2828