510(k) K960200 ยท DYB Introducer, Catheter
INTROSTAT LEAD INTRODUCER
| Applicant | Msi, Inc., Tarpon Springs FL, US |
| Decision | Substantially Equivalent, Jul 2, 1996 |
| Received | Jan 3, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K960200
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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.