The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard(r) Hydrogel/silver-coated Foley Catheter.
| Device ID | K910318 |
| 510k Number | K910318 |
| Device Name: | BARD(R) HYDROGEL/SILVER-COATED FOLEY CATHETER |
| Classification | Catheter, Urological (antimicrobial) And Accessories |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Donna J Wilson |
| Correspondent | Donna J Wilson C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | MJC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-24 |
| Decision Date | 1994-08-18 |