510(k) K121848 ยท MSD Catheter, Hemodialysis, Implanted
SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Unknown, Sep 21, 2012 |
| Received | Jun 25, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K121848
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 4, 2014 | Medical Components, Inc dba MedComp Split Cath III Trays, 16F x 28CM
Product Usage:
The Split Cath III is indicated for use in attaining long term vascular access for hemodialysis and apheresis in adult patients. Terminated |
MSD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.