510(k) K030617 ยท DQX Wire, Guide, Catheter
PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE
| Applicant | Boston Scientific Scimed, Inc., Maple Grove MN, US |
| Decision | Substantially Equivalent, May 21, 2003 |
| Received | Feb 26, 2003 |
| Type | Abbreviated |
| FDA record | Open on fda.gov |
Recalls that name K030617
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2006 | Boston Scientific Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are Terminated |
DQX | None listed |
| Sep 29, 2006 | Boston Scientific Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are Terminated |
DQX | None listed |
| Sep 29, 2006 | Boston Scientific Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires ar Terminated |
DQX | None listed |
| Sep 29, 2006 | Boston Scientific Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires ar Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.