The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bardex Latex-free Temperature-sensing Foley Catheter (uncoated); Bardex Lubri-sil Temperature-sensing Foley Catheter (lu.
| Device ID | K003289 |
| 510k Number | K003289 |
| Device Name: | BARDEX LATEX-FREE TEMPERATURE-SENSING FOLEY CATHETER (UNCOATED); BARDEX LUBRI-SIL TEMPERATURE-SENSING FOLEY CATHETER (LU |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | George C Abernathy |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2000-10-20 |
| Decision Date | 2001-01-05 |