Atlas FDA

ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT

FDA 510(k) clearance K102796 · decided 2010-12-15

Clearance details

K-number
K102796
Device name
ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT
Applicant
AngioDynamics, Inc.
Decision
Substantially Equivalent
Date received
2010-09-27
Decision date
2010-12-15
Days to decision
79 days
Clearance type
Traditional
Product code
GEX
Device class
2
Regulation number
878.4810
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Queensburgy, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AngioDynamics VenaCure EVLT NeverTouch-FRS PROCEDURE KIT under the following labeling: 1) recall (Z-1406-2013)Angiodynamics, Inc.2013-05-25
VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Kit recall (Z-0400-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Kit recall (Z-0401-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouc recall (Z-0402-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouc recall (Z-0403-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch - FRS .018" System PROCEDURE KIT Featuring Gold-Tipped Fiber, 25 recall (Z-0404-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch - FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 90 cm, VC EVLT N recall (Z-0405-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 4 recall (Z-0406-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch - FRS w/19 ga Needle PROCEDURE KIT Featuring Gold-Tipped Fiber, 6 recall (Z-0407-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 recall (Z-0408-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch - FRS .018 " System PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 recall (Z-0409-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, NeverTouch Proc recall (Z-0410-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, NeverTouch Proc recall (Z-0411-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 45 cm, VenaCure Ne recall (Z-0412-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VenaCure Ne recall (Z-0413-2012)Angiodynamics Worldwide Headquarters2012-01-11
VenaCure EVLT NeverTouch-FRS PROCEDURE KIT Featuring Gold-Tipped Fiber, 65 cm, VC NT FRS 6 recall (Z-0414-2012)Angiodynamics Worldwide Headquarters2012-01-11