DTB — Permanent Pacemaker Electrode Class III

FDA Device Classification

Classification Details

Product Code
DTB
Device Class
Class III
Regulation Number
870.3680
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K061212biotronikBIOTRONIK ENDOCARDIAL PACING LEADSJuly 10, 2006
K041809oscorPERMANENT PACING LEAD, MODEL PY2August 6, 2004
K040569oscorPERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUApril 7, 2004
K031274medtronic vascularMODEL 5071 MYOCARDIAL PACING LEADMay 22, 2003
K031210metronicMODEL 4951M MYOCARDIAL UNIPOLAR LEADMay 16, 2003
K023205biotronikELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPApril 24, 2003
K024053oscorPERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJBJanuary 31, 2003
K023803biotronikMODIFICATION TO BIOTRONIK'S STERILIZATION PROCESSDecember 11, 2002
K023099biotronikAROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBPOctober 18, 2002
K021217biotronikAROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBPMay 1, 2002
K010281biotronikMEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBPApril 9, 2002
K020669oscorPERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJBMarch 28, 2002
K013339oscorPERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELSNovember 8, 2001
K003918oscorOSCOR PERMANENT PACING LEAD RZ MODEL SERIESMay 22, 2001
K003072biotronikPACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIESJanuary 9, 2001
K001413biotronikELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668June 2, 2000
K994240biotronikEX 45-BP, MODEL 330 132; EX 53-BP, MODEL 130 018; EX 60-BP, MODEL 330 133April 13, 2000
K993448ela medicalSTELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAApril 10, 2000
K000763biotronik, gmbh andPX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051April 6, 2000
K000029ela medicalSTELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHAApril 4, 2000