The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bardex I.c.plus Foley Catheter With Silver Salts In Hydrogel Coating, Model 3cc Balloon: 17008,170010,5cc Balloon.
| Device ID | K002612 |
| 510k Number | K002612 |
| Device Name: | BARDEX I.C.PLUS FOLEY CATHETER WITH SILVER SALTS IN HYDROGEL COATING, MODEL 3CC BALLOON: 17008,170010,5CC BALLOON |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Georgia C Abernathy |
| Correspondent | Georgia C Abernathy C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-21 |
| Decision Date | 2002-09-03 |