510(k) K934802 ยท LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
THEREX LOW-PROFILE PORT-TITANIUM
| Applicant | Therex Corp., Walpole MA, US |
| Decision | Substantially Equivalent, Mar 22, 1994 |
| Received | Oct 7, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934802
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 19, 2006 | Arrow International Inc Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter.
Latex-Free Low Profile Port. 10 Fr. Introducer Kit.
Ref Product No. AP-06042. Terminated |
LJT | None listed |
| Jul 20, 2004 | Arrow International Inc Arrow A Port with Attachable Silicone Rubber Catheters/10 Fr.
Introducer Kit Implantable Vascular Access System (Product # AP-06520)
Product # AP-06520 kit contains 1 implantable titanium port, 2 att Terminated |
DYB | None listed |
| Jul 20, 2004 | Arrow International Inc Arrow A Port with Attachable Silicone Rubber Catheters Implantable Vascular Access System (Product # AP-01510) .
Product # AP-01510 kit contains 1 implantable titanium port, 2 attachable silicone rubb Terminated |
DYB | None listed |
| Jul 20, 2004 | Arrow International Inc Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr. Introducer Kit Implantable (Product # AP-06042) [NB: titanium port].
Product # AP-06042 kit contains 1 low profile implantable t Terminated |
DYB | None listed |
| Jul 20, 2004 | Arrow International Inc Arrow Low Profile Port with Attachable Silicone Rubber Catheters/10 Fr.
Introducer Kit Implantable Vascular Access System (Product # AP-06022) [NB:
plastic port]
Product # AP-06022 kit contains 1 lo Terminated |
DYB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.