Atlas FDA

PHOENIX MODELS 250/251 PULSE GENERATORS

FDA 510(k) clearance K855081 · decided 1986-03-07

Clearance details

K-number
K855081
Device name
PHOENIX MODELS 250/251 PULSE GENERATORS
Applicant
Pacesetter Systems
Decision
Substantially Equivalent
Date received
1985-12-19
Decision date
1986-03-07
Days to decision
78 days
Clearance type
Traditional
Product code
DXY
Device class
3
Regulation number
870.3610
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Sylmar, CA, 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
CARBON TIP CARDIAC PACING LEAD (P800041/S015)Pacesetter Systems1996-01-04
CARBON TIP CARDIAC PACING LEAD (P800041/S014)Pacesetter Systems1994-10-17
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S011)Pacesetter Systems1994-05-25
CARBON TIPPED LEAD ALT.PROD.TRAYS (P800041/S012)Pacesetter Systems1992-11-18
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S010)Pacesetter Systems1990-12-18
CARBON TIPPED LEAD MODELS 1085S,1085M,& 1085K (P800041/S009)Pacesetter Systems1990-12-10
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S008)Pacesetter Systems1989-06-19
ENDOCARDIAL PACEMAKER LEAD W/CARBON TIP (P800041/S007)Pacesetter Systems1987-06-22