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510(k) K930770

Device
Medtronic Minix & Minix St Pulse Generators
Applicant
MEDTRONIC VASCULAR
510(k) number
K930770
Product code
DXY
Decision
Substantially Equivalent (SESE)
Decision date
1993-05-14
Date received
1993-02-16
Regulation
870.3610
Classification name
Implantable Pacemaker Pulse-Generator
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
3
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JOHN M OTTO
Address
7000 Central Ave., NE Minneapolis MN US 55432 55432

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXY#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K993434PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-ABiotronik, Inc.1999-11-10
K970072OPUS S MODEL 4121 AND 4124 PACEMAKERSEla Medical, Inc.1997-08-29
K945627PIKOS LP 01, PIKOS LP E01Biotronik, Inc.1996-03-04
K954092ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)Medtronic Vascular1995-12-15
K953866MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)Medtronic Vascular1995-12-15
K953417MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORSCook Pacemaker Corp.1995-09-29
K952328NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01Biotronik, Inc.1995-09-29
K952364OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)Ela Medical, Inc.1995-09-01
K940039PELLETHANE 75DMedtronic Vascular1995-07-12
K950751TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULESMedtronic Vascular1995-05-15
K946188CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKERCardiac Control Systems, Inc.1995-05-15
K950210CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKERCardiac Control Systems, Inc.1995-05-03
K941937PIKOS E 01-BBiotronik, Inc.1994-08-30
K932884MINIX/MINIX ST PULSE GENERATORSMedtronic Vascular1994-05-02
K923026PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKERBiotronik, GmbH & Co.1993-08-19