510(k) K963257 ยท LJS Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
PERIPHERALLY INSERTED MEDLINE CATHETER
| Applicant | Arrow Intl., Inc., Reading PA, US |
| Decision | Substantially Equivalent, Mar 4, 1997 |
| Received | Aug 19, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963257
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 17, 2018 | Arrow International Inc Peripherally Inserted Midline Catheter Kit with Placement Wire, REF MK-02031-TW
Product Usage:
To provide real time tip location information of a central venous catheter by utilization of ECG to obse Terminated |
LJS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.