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510(k) K892804

Device
NEWCHILL(TM) CARDIAC INSULATOR
Applicant
ACACIA LABORATORIES, INC.
510(k) number
K892804
Product code
DWS  
Decision
Substantially Equivalent (SESE)
Decision date
1989-07-14
Date received
1989-04-17
Regulation
870.4500
Classification name
Instruments, Surgical, Cardiovascular
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
WILLIAM A GOOLSBEE
Address
1010 Hathaway Ave. Santa Ana CA US 92705 92705

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWS  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic Vascular2002-10-09
K964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.1997-01-30
K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.1996-11-19
K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.1996-05-15
K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical Systems1996-04-19
K960144G.E. STERILE CT BIOPSY TRAYGE Medical Systems1996-04-15
K960143G.E. STERILE DIGITAL ANGIOGRAPHIC TRAYGE Medical Systems1996-04-09
K934727REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELERCardiac Pacemakers, Inc.1994-01-10
K900379HYCULT DIAMOND CORONARY BYPASS KNIFESt. Jude Medical, Inc.1990-03-19
K896307INSULATION PADBio-Vascular, Inc.1990-01-19
K894738MODEL 6888 LEAD TUNNELERCardiac Pacemakers, Inc.1989-09-13
K893436MODIFIED STERILIZATION METHOD OF PTI HEART-LIFTPioneering Technologies, Inc.1989-07-14
K891000MODIFIED EXTERNAL PADInstromedix, Inc.1989-05-19
K890432DEKNATEL HIGH PRECISION VASCULAR PUNCH(TM)Deknatel, Inc.1989-04-13
K890707PHRENIC NERVE PAD & NERVE PAD W/1/4 PERCARDIALDlp, Inc.1989-04-10

Legacy Summary#

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FDA Review#

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