The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Aquaguide Ureteral Conduit.
| Device ID | K030438 |
| 510k Number | K030438 |
| Device Name: | BARD AQUAGUIDE URETERAL CONDUIT |
| Classification | Endoscopic Access Overtube, Gastroenterology-urology |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | Fran Harrison |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | FED |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-02-11 |
| Decision Date | 2003-03-17 |
| Summary: | summary |