Data / Medical devices / United States / Best Vascular, Inc.
Best Vascular, Inc.: FDA-registered device maker in Norcross, GA, United States, 1 PMA approval
Best Vascular, Inc. is registered with the FDA (registration 1062385) in Norcross, GA, United States. It lists 1 device type. The FDA files 1 PMA approval under its listings, the newest dated November 3, 2000. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1062385
- FEI number
- 3000205626
- Address
- 4350 International BLVD., Norcross, GA, United States, 30093
- Owner or operator
- Best Vascular, Inc. (10030863)
- Roles
- Manufacturer
- First device listed
- November 19, 2009
- Registered through
- 2026
- Brand names listed
- Beta-Cath(TM) System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Intravascular Radiation Delivery System | MOU | 3 | Manufacturer | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 3, 2000 | P000018 | BETA-CATH (TM) SYSTEM | MOU | 48 | September 26, 2024 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 25, 2002 | 25139 | Not yet classified | Terminated | Novoste, Beta-Cath 3.5F System, New B-Rail 3.5F Delivery Catheter, with Indicator of Source Train (IST), Novoste Corporate, 3890 Steve Reynolds Blvd, Norcross, GA 30093,,, 1-800-NOVOSTE (), www.novoste.com. | Mislabeling. Source calibrated incorrectly, resultant dose rate lower than expected. | accessdata.fda.gov |
Updated September 26, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.