The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bardex, Lubri-sil And Lubri-sil Ic All-silicone Foley Catheters.
| Device ID | K040504 |
| 510k Number | K040504 |
| Device Name: | BARDEX, LUBRI-SIL AND LUBRI-SIL IC ALL-SILICONE FOLEY CATHETERS |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | John C Knorpp |
| Correspondent | John C Knorpp C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-27 |
| Decision Date | 2004-05-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817643020308 | K040504 | 000 |
| 00817643020292 | K040504 | 000 |
| 00817643020193 | K040504 | 000 |
| 00817643020186 | K040504 | 000 |
| 00817643020179 | K040504 | 000 |
| 00817643020162 | K040504 | 000 |
| 00817643020155 | K040504 | 000 |