510(k) K122785 ยท EZD Catheter, Straight
HYDROSIL; MAGIC; PERSONAL CATHETER
| Applicant | Rochester Medical Corp., Stewartville MN, US |
| Decision | Substantially Equivalent, May 14, 2013 |
| Received | Sep 11, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122785
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 4, 2018 | C.R. Bard, Inc. HydroSil Gripper Intermittent Catheters- 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch. MGC3
Product Usage Intermittent catheters are intended for urinary blad Terminated |
EZD | None listed |
| Apr 4, 2018 | C.R. Bard, Inc. Magic 3 Intermittent Catheters- 12 Male - 30 catheters per box, each catheter is packaged in an individual pouch. Urinary catheter. Terminated |
EZD | None listed |
| Apr 4, 2018 | C.R. Bard, Inc. Personal Intermittent Catheters- 16" and 10" lengths - 30 catheters per box, each catheter is packaged in an individual pouch, Item Numbers: 50612, 50614, 50616, 50618, 52306, 52308, 52310, 52606, 52 Terminated |
EZD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.