The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bn-74 Coated Bardex All Silicone Cath.
| Device ID | K821272 |
| 510k Number | K821272 |
| Device Name: | BN-74 COATED BARDEX ALL SILICONE CATH |
| Classification | Catheter, Urological |
| Applicant | C.R. BARD, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-05-03 |
| Decision Date | 1982-06-22 |