510(k) K033477 ยท MJC Catheter, Urological (Antimicrobial) And Accessories
HYDROPHILIC-ANTIBACTERIAL INTERMITTENT CATHETER, INTERMITTENT CATHETER CLOSED SYSTEM KIT
| Applicant | Rochester Medical Corp., Stewartville MN, US |
| Decision | Substantially Equivalent, Jun 10, 2004 |
| Received | Nov 3, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K033477
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 28, 2017 | C.R. Bard, Inc. Bard Magic 3 Antibacterial Hydrophilic Intermittent Catheter Female, 14 FR (30/box), Rx Only intended for urinary bladder drainage in patients requiring catheterization for management of incontinence, Terminated |
MJC | None listed |
| Oct 5, 2016 | C.R. Bard, Inc. Magic3 Antibacterial Hydrophilic Intermittent Catheter, Male 14 Fr. (30/Box), Sterile
Product Usage:
The catheter is an all silicone, single lumen, drainage tube with drainage eyes at the proximal en Terminated |
MJC | None listed |
| Nov 2, 2015 | C.R. Bard, Inc. Antibacterial Hydro Personal Catheter, Male 12 Fr, Product Code 63512, sold in boxes of 30 units Terminated |
MJC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.