Atlas FDA

PVS 2000 SYNCHRO2 GUIDEWIRE

FDA 510(k) clearance K053268 · decided 2006-03-13

Clearance details

K-number
K053268
Device name
PVS 2000 SYNCHRO2 GUIDEWIRE
Applicant
Boston Scientific - Precision Vascular
Decision
Substantially Equivalent
Date received
2005-11-23
Decision date
2006-03-13
Days to decision
110 days
Clearance type
Special
Product code
DQX
Device class
2
Regulation number
870.1330
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
West Valley City, UT, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are avai recall (Z-1941-2024)Stryker Neurovascular2024-05-31
Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft. Boston Scientific; Made in recall (Z-0868-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped; Boston Scienti recall (Z-0869-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft; Boston Scientific Corpora recall (Z-0870-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped; Boston Scienti recall (Z-0871-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Cor recall (Z-0872-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Boston Sci recall (Z-0873-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; Boston Scientific Cor recall (Z-0874-2011)Boston Scientific Corporation2011-01-07
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Boston Sci recall (Z-0875-2011)Boston Scientific Corporation2011-01-07
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm recall (Z-2068-2010)Boston Scientific Corporation2010-07-22
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 200 recall (Z-2069-2010)Boston Scientific Corporation2010-07-22
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 300 cm x 10 cm recall (Z-2070-2010)Boston Scientific Corporation2010-07-22
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 300 recall (Z-2071-2010)Boston Scientific Corporation2010-07-22