FEI 3000205626
Best Vascular, Inc.
4350 INTERNATIONAL BLVD., NORCROSS, GA, US
MDR events8All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 product codes
Recent MDR events
8 on file
- BETA-CATH SYSTEMJun 2, 2021Injury3000205626-2021-00001
- BEST VASCULAR INC NOVOSTE B-RAIL DELIVERY CATHMay 28, 2021InjuryMW5101623
- BETH CATH ACTIVE TRANSFER DEVICESep 27, 2019Malfunction9128812
- B-RAILFeb 2, 2015Malfunction4507759
- BETA-CATH 3.5F SYSTEMDec 23, 2014Malfunction4384678
- NOVOSTE B-RAILJul 2, 2013Malfunction3225999
- NOVOSTE BETA-CATH IVBJun 12, 2013Malfunction3208703
- NOVOSTE BETACATH SYSTEMMay 5, 2009Malfunction1381021
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3000205626.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 11, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jul 11, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(b)Jul 11, 2025
Documentation
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.