The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bard Male External Catheter.
| Device ID | K802433 |
| 510k Number | K802433 |
| Device Name: | BARD MALE EXTERNAL CATHETER |
| Classification | Collector, Urine, (and Accessories) For Indwelling Catheter |
| Applicant | C.R. BARD, INC. 110 MARSHALL DRIVE Warrandale, PA 15086 |
| Product Code | KNX |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-06 |
| Decision Date | 1980-10-31 |