510(k) K050964 ยท DQX Wire, Guide, Catheter
PV 1900 SYNCHRO 0.016 GUIDEWIRE
| Applicant | Boston Scientific - Precision Vascular, West Valley City UT, US |
| Decision | Substantially Equivalent, Jun 13, 2005 |
| Received | Apr 18, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050964
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Scientific Corpor Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 45 cm, tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Scientific Corpor Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Sci Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Sci Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Sci Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Sci Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.