Atlas FDA

AVEA

FDA 510(k) clearance K013642 · decided 2002-05-22

Clearance details

K-number
K013642
Device name
AVEA
Applicant
Bird Products Corp.
Decision
Substantially Equivalent
Date received
2001-11-05
Decision date
2002-05-22
Days to decision
198 days
Clearance type
Traditional
Product code
CBK
Device class
2
Regulation number
868.5895
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Palm Spring, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to recall (Z-1888-2016)Carefusion 211 Inc dba Carefusion2016-06-13
AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mecha recall (Z-1889-2016)Carefusion 211 Inc dba Carefusion2016-06-13
AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator i recall (Z-1890-2016)Carefusion 211 Inc dba Carefusion2016-06-13
AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator i recall (Z-1891-2016)Carefusion 211 Inc dba Carefusion2016-06-13
AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intend recall (Z-1892-2016)Carefusion 211 Inc dba Carefusion2016-06-13
AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous v recall (Z-1893-2016)Carefusion 211 Inc dba Carefusion2016-06-13
TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad recall (Z-1894-2016)Carefusion 211 Inc dba Carefusion2016-06-13
Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to recall (Z-1895-2016)Carefusion 211 Inc dba Carefusion2016-06-13
Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control recall (Z-1896-2016)Carefusion 211 Inc dba Carefusion2016-06-13
Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechani recall (Z-1897-2016)Carefusion 211 Inc dba Carefusion2016-06-13
AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically contr recall (Z-1898-2016)Carefusion 211 Inc dba Carefusion2016-06-13
AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control o recall (Z-1899-2016)Carefusion 211 Inc dba Carefusion2016-06-13
Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 recall (Z-2273-2013)Carefusion 211 Inc dba Carefusion2013-09-27
AVEA Ventilator (Catalog Code 17310, 17311, 17312). The AVEA is intended to provide contin recall (Z-0510-2012)Carefusion 211 Inc2012-01-11
VIASYS AVEA Ventilator, Catalog numbers: 17210-00 (USA Comprehensive Version) recall (Z-0982-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14
VIASYS AVEA Ventilator, Catalog numbers: 17210-03 (Italian Comprehensive Version) recall (Z-0983-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14
VIASYS AVEA Ventilator, Catalog numbers: 17310-00 (USA Comprehensive Version) recall (Z-0984-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14
VIASYS AVEA Ventilator, Catalog numbers: 17311-00 (USA Standard Version) recall (Z-0985-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14
VIASYS AVEA Ventilator, Catalog numbers: 17312-00 (USA Standard with Compressor Version) recall (Z-0986-2008)Viasys Respiratory Care, Inc.dba Bird Products2008-05-14