The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bardex All-silicone, Bardex Lubri-sil, And Bardex Lubri-sil I.c. Temperature-sensing Foley Catheters.
| Device ID | K070582 |
| 510k Number | K070582 |
| Device Name: | BARDEX ALL-SILICONE, BARDEX LUBRI-SIL, AND BARDEX LUBRI-SIL I.C. TEMPERATURE-SENSING FOLEY CATHETERS |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Skip Rimer |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2007-03-01 |
| Decision Date | 2007-12-07 |
| Summary: | summary |