C.R. Bard, Inc. · Class II · Cleared Jan 5, 2001
| K-number | K003289 |
| Device name | BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU |
| Applicant | C.R. Bard, Inc. |
| Product code | EZL |
| Device class | Class II |
| Decision date | Jan 5, 2001 |
| Decision | Substantially Equivalent |
| Regulation | 876.5130 |
AI extraction for this record is queued and will appear within 24 hours. View full FDA record →
View the full FDA submission: accessdata.fda.gov