510(k) K893439 ยท LFJ Catheter, Subclavian
HEMO-CATH SILICONE DOUBLE LUMEN CATH SL28C & SL40C
| Applicant | Medical Components, Inc., Harleysville PA, US |
| Decision | Substantially Equivalent, Jun 13, 1989 |
| Received | May 3, 1989 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K893439
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2019 | Medical Components, Inc dba MedComp 14F SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061422 Terminated |
LFJ | None listed |
| Mar 13, 2019 | Medical Components, Inc dba MedComp 14F x 20CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061423
Product Usage: An aid for introducing a hemodialysis catheter Terminated |
LFJ | None listed |
| Mar 13, 2019 | Medical Components, Inc dba MedComp 14F x 24CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061424
Product Usage: An aid for introducing a hemodialysis catheter Terminated |
LFJ | None listed |
| Mar 13, 2019 | Medical Components, Inc dba MedComp 14F x 30CM SLX Double Lumen Full Tray Hemodialysis catheter insertion kits, Item No. MC061425
Product Usage: An aid for introducing a hemodialysis catheter Terminated |
LFJ | None listed |
| Feb 10, 2015 | Medical Components, Inc dba MedComp Hemodialysis Catheters and PICCs: Product identification: MCDLTSL24P (SF X 24CM LT HEMO-CATH), MC061422 (14FX15CM SLX DBL LMN ST CATH),
MRCTP41017 (4F X 55CM SINGLE CT PICC), MRCTP52007 (5F DUAL PRO Terminated |
LFJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.