Atlas FDA

MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F

FDA 510(k) clearance K062887 · decided 2006-10-26

Clearance details

K-number
K062887
Device name
MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL RF-310F
Applicant
Bard Peripheral Vascular
Decision
Substantially Equivalent
Date received
2006-09-26
Decision date
2006-10-26
Days to decision
30 days
Clearance type
Special
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Tempe, AZ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Flair Endovascular Stent Graft (P060002/S040)Bard Peripheral Vascular2018-10-11
FLAIR ENDOVASCULAR STENT GRAFT (P060002/S038)Bard Peripheral Vascular2017-11-28
Flair Endovascular Stent Graft (P060002/S039)Bard Peripheral Vascular2017-07-19
FLAIR ENDOVASCULAR STENT GRAFT (P060002/S036)Bard Peripheral Vascular2016-05-16
FLAIR ENDOVASCULAR STENT GRAFT (P060002/S034)Bard Peripheral Vascular2014-08-13
BARD FLAIR ENDOVASCULAR STENT GRAFT (P060002/S035)Bard Peripheral Vascular2014-04-23
FLAIR ENDOVASCULAR STENT GRAFT (P060002/S033)Bard Peripheral Vascular2013-09-16
FLAIR ENDOVASCULAR STENT GRAFT (P060002/S032)Bard Peripheral Vascular2013-05-29