510(k) K053268 ยท DQX Wire, Guide, Catheter
PVS 2000 SYNCHRO2 GUIDEWIRE
| Applicant | Boston Scientific - Precision Vascular, West Valley City UT, US |
| Decision | Substantially Equivalent, Mar 13, 2006 |
| Received | Nov 23, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K053268
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 31, 2024 | Stryker Neurovascular The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewire Open, Classified |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft.
Boston Scientific; Made in: 2405 West Orton Circle, West Valley City, UT 84119
The Synchro guidewire series is intended for general in Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston S Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Scientific C Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston S Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Scientif Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Bost Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Scientif Terminated |
DQX | None listed |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Bost Terminated |
DQX | None listed |
| Jul 22, 2010 | Boston Scientific Corporation Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm, REF 50-810, UPN M001508100 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Vall Terminated |
DQX | None listed |
| Jul 22, 2010 | Boston Scientific Corporation Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 200 cm x 10 cm, REF 50-811, UPN M001508110 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle Terminated |
DQX | None listed |
| Jul 22, 2010 | Boston Scientific Corporation Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 300 cm x 10 cm, REF 50-814, UPN M001508140 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Vall Terminated |
DQX | None listed |
| Jul 22, 2010 | Boston Scientific Corporation Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 300 cm x 10 cm, REF 50-815, UPN M001508150 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle Terminated |
DQX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.