510(k) K781846 ยท KGZ Accessories, Catheter
ADAPTER, CATHETER SHEATH
| Applicant | Arrow Intl., Inc., Walker MI, US |
| Decision | Substantially Equivalent, Dec 12, 1978 |
| Received | Nov 1, 1978 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K781846
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 25, 2010 | Arrow International Inc Arrow Percutaneous Sheath Introducer Kit with Integral Hemostasis Valve/Side Port for use with 7.5 Fr. Catheters; Catalog number AJ-09801 Terminated |
KGZ | None listed |
| May 5, 2010 | Arrow International Inc Percutaneous Sheath Introducer (PSI) Kit with Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605
Permits venous Terminated |
KGZ | None listed |
| Jun 24, 2009 | Arrow International Inc Arrow Percutaneous Sheath Introducers Terminated |
KGZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.