The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Inlay Lubricious Double Pigtail Ureteral Stent With Suture (hereinafter Referred To As Bard Lubricious Ureteral Ste.
| Device ID | K983498 |
| 510k Number | K983498 |
| Device Name: | BARD INLAY LUBRICIOUS DOUBLE PIGTAIL URETERAL STENT WITH SUTURE (HEREINAFTER REFERRED TO AS BARD LUBRICIOUS URETERAL STE |
| Classification | Stent, Ureteral |
| 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 | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-10-05 |
| Decision Date | 1998-12-15 |
| Summary: | summary |