The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Dual Lumen Ureteral Catheter.
| Device ID | K032521 |
| 510k Number | K032521 |
| Device Name: | BARD DUAL LUMEN URETERAL CATHETER |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Frances Harrison |
| Correspondent | Frances Harrison C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-15 |
| Decision Date | 2003-11-14 |
| Summary: | summary |