510(k) K983927 ยท DQT Occluder, Catheter Tip
GT1 FLOPPY, GT1 HI-PER FLEX, GT1 LIGHT SUPPORT
| Applicant | Arterial Vascular Engineering, Inc., Billerica MA, US |
| Decision | Substantially Equivalent, Mar 11, 1999 |
| Received | Nov 5, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983927
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 15, 2013 | Medtronic Vascular Zinger Stainless Steel Workhorse Guidewire; Models: ZNGRLS180HJ, ZNGRLS180HS, ZNGRMS180HJ, ZNGRMS180HS, ZNGRMS180S, ZNGRS180HJ, ZNGRS180HS, ZNGRS180S
Medtronic guide wires are steerable guide wires Terminated |
DQT | None listed |
| Nov 15, 2013 | Medtronic Vascular ZINGER Steerable Guidewire; Models: LVZRLS180J, LVZRLS180S, LVZRMS180J, LVZRMS180S, LVZRXT180J, LVZRXT180S
Medtronic guide wires are steerable guide wires that are used for the introduction and place Terminated |
DQT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.