Atlas FDA

LIFESTENT FLEXSTART BILIARY STENT SYSTEM

FDA 510(k) clearance K053404 · decided 2005-12-21

Clearance details

K-number
K053404
Device name
LIFESTENT FLEXSTART BILIARY STENT SYSTEM
Applicant
Edwards Lifesciences, LLC
Decision
Unknown
Date received
2005-12-07
Decision date
2005-12-21
Days to decision
14 days
Clearance type
Special
Product code
FGE
Device class
2
Regulation number
876.5010
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Irvine, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0035-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0036-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0037-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0038-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0039-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0040-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0041-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0042-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0043-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0044-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0045-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0046-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0047-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0048-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0049-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0050-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0051-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0052-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0053-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0054-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0055-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0056-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0057-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0058-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0059-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0060-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0061-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0062-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0063-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0064-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0065-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0066-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0067-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0068-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0069-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0070-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0071-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0072-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0073-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0074-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0075-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0076-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0077-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0078-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0079-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0080-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0081-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0082-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0083-2009)Bard Peripheral Vascular Inc2008-10-10
Edwards Lifesciences LifeStent FlexStar Self-Expanding Biliary Stent System, Edwards Lifes recall (Z-0084-2009)Bard Peripheral Vascular Inc2008-10-10

PMA approvals by this applicant

RecordFirmDate
SAPIEN M3 Transcatheter Mitral Valve Replacement System (P250019)Edwards Lifesciences, LLC2025-12-22
Edwards SAPIEN 3 Ultra RESILIA Transcatheter Heart Valve, Models 9755RSL20, 9755RSL23, 9755RSL26, and 9755RSL29 (P140031/S197)Edwards Lifesciences, LLC2025-12-17
Edwards INSPIRIS RESILIA Aortic Valve, Model 11500A, Sizes 19mm, 21mm, 23mm, 25mm, 27mm, and 29mm; Edwards KONECT RESILI (P150048/S095)Edwards Lifesciences, LLC2025-12-17
Edwards SAPIEN 3 Ultra Transcatheter Heart Valve (sizes 20mm, 23mm, 26mm) 9750TFX; Edwards SAPIEN 3 Ultra RESILIA Transc (P140031/S196)Edwards Lifesciences, LLC2025-12-17
EVOQUE Tricuspid Valve Replacement System (P230013/S019)Edwards Lifesciences, LLC2025-11-19
Edwards EVOQUE Tricuspid Valve Replacement System (P230013/S013)Edwards Lifesciences, LLC2025-10-31
TRIFORMIS RESILIA Tricuspid Valve (P150048/S092)Edwards Lifesciences, LLC2025-10-27
Edwards SAPIEN 3 Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra Transcatheter Heart Valve; Edwards SAPIEN 3 Ultra RES (P140031/S195)Edwards Lifesciences, LLC2025-10-16