510(k) K883880 ยท DQX Wire, Guide, Catheter
KATZEN THROMBOLYSIS GUIDEWIRE
| Applicant | Medi-Tech, Inc., Watertown MA, US |
| Decision | Substantially Equivalent, Apr 6, 1989 |
| Received | Sep 13, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K883880
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 23, 2011 | Boston Scientific Corporation Katzen" Infusion Wire, 0.035 in x 180 cm,
UPN Product No. M001461930,
RED Catalog No. 46-193,
Made in USA 8600.
Boston Scientific.
NW 41 Street, Miami, FL 33166.
Intended for the infusion of the Terminated |
DQX | None listed |
| Mar 21, 2007 | Boston Scientific Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for t Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.