Atlas FDA

COOK PACEMAKER 215 UNIPOLAR CARDIAC-

FDA 510(k) clearance K841928 · decided 1984-07-11

Clearance details

K-number
K841928
Device name
COOK PACEMAKER 215 UNIPOLAR CARDIAC-
Applicant
Cook Pacemaker Corp.
Decision
Substantially Equivalent
Date received
1984-05-10
Decision date
1984-07-11
Days to decision
62 days
Clearance type
Traditional
Product code
DXY
Device class
3
Regulation number
870.3610
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mchenry, IL, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (K993434)Biotronik, Inc.1999-11-10
OPUS S MODEL 4121 AND 4124 PACEMAKERS (K970072)Ela Medical, Inc.1997-08-29
PIKOS LP 01, PIKOS LP E01 (K945627)Biotronik, Inc.1996-03-04
MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (K953866)Medtronic Vascular1995-12-15
ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (K954092)Medtronic Vascular1995-12-15
MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (K953417)Cook Pacemaker Corp.1995-09-29
NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (K952328)Biotronik, Inc.1995-09-29
OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (K952364)Ela Medical, Inc.1995-09-01
PELLETHANE 75D (K940039)Medtronic Vascular1995-07-12
TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES (K950751)Medtronic Vascular1995-05-15
CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (K946188)Cardiac Control Systems, Inc.1995-05-15
CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (K950210)Cardiac Control Systems, Inc.1995-05-03

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS. (P870054/S014)Cook Pacemaker Corp.1995-07-12
MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS (P870054/S009)Cook Pacemaker Corp.1990-10-31
MODEL Q (UNIPOLAR) & R (BIPOLAR) ENDOCARDIAL LEADS (P870054/S010)Cook Pacemaker Corp.1990-06-19
KELVIN (R) PACING SYSTEM (P870054/S011)Cook Pacemaker Corp.1990-03-19
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S005)Cook Pacemaker Corp.1989-12-06
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S003)Cook Pacemaker Corp.1989-09-19
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S006)Cook Pacemaker Corp.1989-07-31
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S004)Cook Pacemaker Corp.1989-06-20