510(k) K802665 ยท KOD Catheter, Urological
TOUCHLESS CLEAN-CATH
| Applicant | Diamed Division Ill. Tool Works, Inc., Mchenry IL, US |
| Decision | Substantially Equivalent, Nov 12, 1980 |
| Received | Oct 28, 1980 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K802665
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2026 | C.R. Bard Inc Products that contain the Pericare Wipes:
SureStep Intermittent Catheter Tray
REF:
INTP16
INTS14
INTS14C
INTS16
INTS16C
PEDINTS06
PEDINTS08
PEDINTS10
UDI code:
00801741183300 10801741183307
008017411 Open, Classified |
KOD | None listed |
| Jan 11, 2021 | C.R. Bard, Inc. Bard Clean-Cath Intermittent Catheter, 12 French female length (catheter, urological) - Product Usage: for urological use only. Terminated |
KOD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.