The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Bardex I.c 4-way Foley Catheter Model 1865sixx Xx = 18,20,22,24.
| Device ID | K983101 |
| 510k Number | K983101 |
| Device Name: | BARDEX I.C 4-WAY FOLEY CATHETER MODEL 1865SIXX XX = 18,20,22,24 |
| Classification | Catheter, Urological (antimicrobial) And Accessories |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30209 |
| Contact | Georgia C Abernathy |
| Correspondent | Georgia C Abernathy C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30209 |
| Product Code | MJC |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-03 |
| Decision Date | 1998-11-03 |
| Summary: | summary |