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510(k) K870186

Device
ENDOMYOCARDIAL BIOPSY DEVICE
Applicant
MANSFIELD SCIENTIFIC, INC.
510(k) number
K870186
Product code
DWZ  
Decision
Substantially Equivalent (SESE)
Decision date
1987-02-20
Date received
1987-01-16
Regulation
870.4075
Classification name
Device, Biopsy, Endomyocardial
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
BRUCE BEAUCHEMIN
Address
135 Forbes Blvd. Mansfield MA US 02048 02048

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code DWZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K252722Biopsy ForcepsFehling Instruments GmbH2025-09-30
K170726Biopsy ForcepsFehling Instruments GmbH & Co. KG2017-06-02
K072051NOVATOME, MODEL: SU101-50Scholten Surgical Instruments, Inc.2007-10-03
K010473SPARROWHAWK DISPOSABLEAtc Technologies, Inc.2001-06-06
K000409MODIFICATION TO T-REX BIOPSY FORCEPSBoston Scientific Corp2000-02-28
K991486ULTRA-CBXMedcanica, Inc.1999-11-05
K974175HEARTPORT ENDOAORTIC CLAMP CATHETERHeartport, Inc.1997-12-16
K973818T-REX BIOPSY FORCEPSBoston Scientific Corp1997-12-16
K951447DYNABITE CARDIOVASCULAR BIOPSY FORCEPSPortlyn Corp.1995-07-27
K933235CORDIS BIPAL 7 /BIOPSY & BIPAL BIOPSY FORCEPS, MODIFCordis Corp.1994-01-06
K932788CORDIS BIPAL 7 BIOPSY FORCEPS WITH A INLINE HANDLECordis Corp.1993-09-01
K921401BIOPSY FORCEPSAnnex Medical, Inc.1992-10-21
K920289CORDIS BIPAL 7 BIOPSY FORCEPSCordis Corp.1992-03-30
K914567CORDIS BIPAL BIOPSY FORCEPSCordis Corp.1991-12-18
K910840VASCULAR BIOPSY FORCEPSVascular Products, Inc.1991-07-15

Legacy Summary#

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FDA Review#

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