Atlas FDA

ELECTRODE, PACEMAKER, PERMANENT

FDA 510(k) clearance K810139 · decided 1981-11-27

Clearance details

K-number
K810139
Device name
ELECTRODE, PACEMAKER, PERMANENT
Applicant
Pacesetter Systems
Decision
Substantially Equivalent
Date received
1981-01-21
Decision date
1981-11-27
Days to decision
310 days
Clearance type
Traditional
Product code
DTB
Device class
3
Regulation number
870.3680
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Walker, MI, 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
BIOTRONIK ENDOCARDIAL PACING LEADS (K061212)Biotronik, Inc.2006-07-10
PERMANENT PACING LEAD, MODEL PY2 (K041809)Oscor, Inc.2004-08-06
PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (K040569)Oscor, Inc.2004-04-07
MODEL 5071 MYOCARDIAL PACING LEAD (K031274)Medtronic Vascular2003-05-22
MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (K031210)Metronic, Inc.2003-05-16
ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (K023205)Biotronik, Inc.2003-04-24
PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (K024053)Oscor, Inc.2003-01-31
MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (K023803)Biotronik, Inc.2002-12-11
AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (K023099)Biotronik, Inc.2002-10-18
AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (K021217)Biotronik, Inc.2002-05-01
MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBP (K010281)Biotronik, Inc.2002-04-09
PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJB (K020669)Oscor, Inc.2002-03-28

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