Product code DTB— Cardiovascular
CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
- Classification name
- Permanent Pacemaker Electrode
- Device class
- Class 3
- Regulation
- 21 CFR 870.3680
- Advisory panel
- Cardiovascular
- Total cleared
- 487
- First cleared
- Most recent
Clearances under product code DTB — page 2
101–200 of 487- K903928 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP
- K903929 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP
- K902002 — MODELS 5069/5071 MYOCARDIAL PACING LEADS
- K896824 — BIOTRONIK'S PS-ENDOCARDIAL LEADS
- K900645 — LASERDISH POLYURETHANE VENTRICULAR LEAD W/TRAILING
- K896742 — FOCUS J81F, J83F, J41F, J43F PACING LEADS
- K902147 — ENDOCARDIAL SCREW-IN LEAD MODEL 1028T
- K901402 — VS-1 LEAD EXT. 033-302, 4.75MM 033-260, 033-458
- K901709 — DNP 60-B UNIPOLAR ENDOCARDIAL LEAD
- K900984 — MODIFIED UNIPOLAR IMPLANT. PACING LEADS W/IS-1
- K900550 — FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T
- K896313 — MEDTRONIC IMPLANTABLE PACING LEADS W/IS-1 CONN.
- K895136 — PERMANENT AND TEMP. PACEMAKER ELECTRODE & LEAD ADA
- K897067 — MODIFIED J-STIFFENER WIRE MATERIAL IN LEAD LINES
- K892528 — FIVE-YEAR STERILE PACKAGING SHELF LIFE
- K895447 — ENDOCARDIAL SCREW-IN LEAD MODEL 1020T
- K896443 — MYOPORE(TM) UNIPOLAR MODELS 1117 & 1118 PACE LEADS
- K893041 — NEW ADHESIVE, PELLETHAN ON POLYURETHANE LEADS-MODI
- K885175 — MYOPORE(TM) UNIPOLAR SUTURELESS MYOCARDIAL LEADS
- K893763 — MODELS 1113 AND 1114 PACEMAKER LEADS
- K894040 — IMPLANTABLE PACING LEADS W/IS-1 CONN., UNIPOLAR
- K890018 — PACEMAKER LEAD ADAPTER
- K891905 — CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE
- K890644 — MEDTRONIC MODEL 5866-45 SIZING SLEEVE
- K890527 — ALTERNATE PACKAGING CONFIGURATION FOR PACING LEADS
- K884697 — HEPARIN BONDING FOR CATHETERS
- K890411 — MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS
- K890412 — MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS
- K890547 — SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS
- K884811 — ACCUFIX AND LASERDISH BIPOLAR VS-1 LEADS
- K885240 — MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD
- K890350 — VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE)
- K890045 — MODEL 6208,6209,6210,6211,6212,6214 (PLI'S)
- K883743 — MEDTRONIC MODEL 4058 PACING LEAD
- K884278 — IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436
- K884394 — PACING LEADS FOCUS T81,T81F,T82F,T83,T83F,T84F
- K883070 — ENCOR UNIPOLAR VS-1 LEADS
- K884005 — ENDOCARDIAL PACING LEADS-ANCHORING SLEEVE MODIFIED
- K882345 — PERMANENT PACING LEADS PYBJ SERIES
- K882462 — PERMANENT PACING LEAD MODEL RXBJ SERIES
- K873772 — CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS
- K883265 — MODEL 329-701 BIPOLAR ACTIVE-FIXATION LEAD
- K884024 — POLYSAFE(TM) IMPLANTABLE PACING LEAD
- K881810 — MEDTRONIC MODEL 4951P
- K883015 — POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP
- K883016 — POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP
- K883203 — MODEL 5866-34A PACEMAKER LEAD ADAPTOR
- K883602 — BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD
- K882452 — MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD
- K874366 — ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201
- K874664 — IMPLANTABLE ELECTRODE LEAD, MODEL 030-446
- K875178 — MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
- K881712 — MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT
- K875100 — MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
- K872126 — MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD
- K880551 — MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD
- K875199 — NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR
- K872971 — PERMANENT MYOCARDIAL LEADS MP SERIES
- K873962 — MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD
- K874205 — ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T
- K874183 — ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD
- K874743 — PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390
- K874792 — MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD
- K874531 — POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD
- K874930 — MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER
- K874167 — MEDTRONIC PERMANENT LEAD INTRODUCER
- K873921 — MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE
- K870885 — MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
- K873931 — MODIFIED MODELS 1025M & 1026T PACING LEAD
- K872731 — PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860
- K865098 — SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438
- K870016 — ARTERIAL BLOOD GASSING MONITORING SYSTEM (ABG)
- K871580 — IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01
- K864618 — IMPLANTABLE ELECTRODE LEAD, MODEL 030-439
- K870357 — ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY
- K871625 — MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER
- K871333 — IMPLANTABLE TINED, TRANS. PACING LEAD/REVIS. LABEL
- K870948 — MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD
- K870610 — RESUBMISSION OF MODEL 030-437 IMPLANT. ELECTRODE
- K870824 — ADDITIONAL CARDIAC PACING LEADS #1020 THROUGH 1035
- K870034 — MODEL PY...U UNIPOLAR & BIPOLAR PACING LEAD
- K864326 — MODEL 366-13 ADAPTAID STEP DOWN ADAPTER
- K862051 — MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD
- K863536 — MEDTRONIC MODEL 5013
- K864153 — PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290
- K864601 — CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD
- K864640 — ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
- K864738 — MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
- K864856 — MODEL 5866-24 PACEMAKER LEAD ADAPTOR
- K864098 — TELECTRONICS SREW-IN/SLIM LINE PACING LEADS
- K864428 — MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER
- K864564 — MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD
- K863921 — DAIG TYPE O4 VS-1 CONNECTOR
- K864002 — MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD
- K864287 — MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD
- K863781 — MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD
- K864047 — MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER
- K864048 — MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER
- K862966 — 3.2MM UNIPOLAR & BIPOLAR LEAD CONNECTORS (VS-1)
- K863480 — BIOTRONIK PERMANENT PACEMAKER ELECTRODE
Data sourced from openFDA. This site is unofficial and independent of the FDA.