FDA.reportPublic FDA data

510(k) K003072

Device
PACING LEADS, GUIDE WIRES, AND VARIOUS ACCESSORIES
Applicant
Biotronik, Inc.
510(k) number
K003072
Product code
DTB
Decision
Substantially Equivalent (SESE)
Decision date
2001-01-09
Date received
2000-10-03
Regulation
870.3680
Classification name
Permanent Pacemaker Electrode
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
3
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Jon Brumbaugh
Address
6024 Jean Rd. Lake Oswego OR US 97035 97035

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTB#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K061212BIOTRONIK ENDOCARDIAL PACING LEADSBiotronik, Inc.2006-07-10
K041809PERMANENT PACING LEAD, MODEL PY2Oscor, Inc.2004-08-06
K040569PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJUOscor, Inc.2004-04-07
K031274MODEL 5071 MYOCARDIAL PACING LEADMedtronic Vascular2003-05-22
K031210MODEL 4951M MYOCARDIAL UNIPOLAR LEADMetronic, Inc.2003-05-16
K023205ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BPBiotronik, Inc.2003-04-24
K024053PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJBOscor, Inc.2003-01-31
K023803MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESSBiotronik, Inc.2002-12-11
K023099AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBPBiotronik, Inc.2002-10-18
K021217AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBPBiotronik, Inc.2002-05-01
K010281MEROX BIPOLAR HIGH IMPEDANCE LEAD MODELS: MEX 53/13-BP; 60/15-BP; 45-JBP; 53-JBPBiotronik, Inc.2002-04-09
K020669PERMANENT PACING LEAD, MODELS PETITE, PETITE R, J, RJ, PETITE B, RB, JB, RJBOscor, Inc.2002-03-28
K013339PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELSOscor, Inc.2001-11-08
K003918OSCOR PERMANENT PACING LEAD RZ MODEL SERIESOscor, Inc.2001-05-22
K001413ELOX 45-BP, MODEL 330 132, EFH-27, MODEL 331 549, EXTENSION TOOL, MODEL 331 668Biotronik, Inc.2000-06-02