Product code DXY— Cardiovascular
IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- Classification name
- Implantable Pacemaker Pulse-Generator
- Device class
- Class 3
- Regulation
- 21 CFR 870.3610
- Advisory panel
- Cardiovascular
- Total cleared
- 461
- First cleared
- Most recent
Clearances under product code DXY — page 2
101–200 of 461- K861422 — PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY
- K862037 — MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN
- K862038 — MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER
- K862071 — MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN
- K860573 — IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR
- K861559 — SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS
- K861140 — PROGRAMALITH III PULSE GENERATOR
- K861009 — BIPOLAR CARDIAC PACEMAKER, MODEL 110
- K852973 — UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762
- K855147 — MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS
- K855081 — PHOENIX MODELS 250/251 PULSE GENERATORS
- K854482 — ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS
- K853400 — CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK
- K853471 — CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA
- K860202 — MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER.
- K860466 — MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN.
- K855171 — TELEMETRY WAND MODEL
- K854560 — IMPLANTABLE PROGRAMMABLE PULSE GENERATOR
- K851968 — CORDIS MULTICOR ST, MODEL 350A
- K852641 — ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER
- K854195 — PROGRAMALITH III MODELS 238 & 239
- K854919 — BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY
- K851365 — SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM
- K854132 — COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS
- K854214 — MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE
- K852339 — SUPRIMA MODEL 254-22
- K852340 — SUPRIMA MODEL 254-24
- K852688 — MEDTRONICS MODELS 8320/8322/8329
- K852748 — CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK
- K854143 — BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS
- K853590 — COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI
- K853651 — COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER
- K853058 — NEOS - M ABP
- K853057 — TRIOS - M
- K853206 — IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW
- K853425 — CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR
- K852435 — CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA
- K853017 — ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251
- K853034 — #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ
- K852431 — SUPRIMA II MODEL 254-26
- K852430 — SUPRIMA II MODEL 253-23
- K852432 — SUPRIMA II MODEL 254-28
- K851420 — MULTICOR S, MODELS 330A/331A
- K844360 — CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS
- K851416 — STANICOR GAMMA 333B/334A
- K851417 — MULTICOR GAMMA MODELS 336/337
- K851418 — OMNI-ATRICOR MODEL 308A
- K851419 — MULTICOR GAMMA 402 SERIES PACER
- K851699 — COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE
- K851861 — PROGRAMALITH III MODEL 249 PULSE GENERATOR
- K850464 — PROGRAMALITH III 240 PULSE GENERATOR
- K844794 — LEPTOS PULSE GENERATOR
- K844795 — NEOS-M PULSE GENERATOR
- K844812 — NEOS - PULSE GENERATOR
- K844841 — KALOS-04 PULSE GENERATOR
- K844842 — NEOS-LP PULSE GENERATOR
- K850252 — QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR
- K851081 — IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II
- K850651 — PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR
- K850384 — CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER
- K842051 — EKG TRANSMITTER MODEL 5134
- K850656 — COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM
- K844793 — SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR
- K844957 — MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR
- K844958 — MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE
- K842193 — MULTILITH PULSE GENERATORS, 1141 & 2141
- K844334 — VIVALITH II 301 PULSE GENERATOR
- K841225 — PULSE GENERATOR 689, 689B & 689L
- K841230 — PULSE GENERATOR 686, 686B 686L
- K841232 — PULSE GENERATOR 696, 696B & 696L
- K842220 — MULTILITH 2 PULSE GENERATOR 1141 & 2141
- K842473 — IMPLANTABLE PROGRAMMABLE PULSE GENERAT
- K842394 — ASTRA 2, ASTRA 3, 4 & 6
- K843837 — MEDTRONIC 5984-5984LP-5985
- K843089 — MEDTRONIC 8437/8438
- K841633 — NEOS LP
- K840748 — LITHIUM PACEMAKER 811-811L & 811XL
- K841635 — LEPTOS
- K841928 — COOK PACEMAKER 215 UNIPOLAR CARDIAC-
- K841983 — COOK PACEMAKER 216 BIPOLAR CARDIAC -
- K841233 — PULSE GENERATOR 678L
- K842081 — COOK PACEMAKER CORP. 115 UNIPOLAR CARDI
- K841226 — PULSE GENERATOR 728, 728B & 728L
- K841228 — PULSE GENERATOR 718B & 718L
- K841231 — PULSE GENERATOR 688B & 688L
- K841229 — PULSE GENERATOR 698, 698B & 698L
- K841636 — NEOS M
- K841950 — PULSE GENERATOR KALOS-04
- K841404 — PRIMA 236-02 NONPROGRAMMABLE CARDIAC
- K840737 — IMPLANTABLE PROGRAMMABLE PULSE GENER
- K841073 — QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE
- K841074 — CARDIAC PULSE GENERATOR 254-18
- K841075 — CARCIAC PULSE GENERATOR 254-20
- K840701 — PACEMAKER 147 VVI-THE OPTINIA
- K833427 — IMPLANTABLE BIPOLAR CARDIAC PULSE GEN
- K833428 — IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN
- K833519 — PULSE GENERATOR MODEL 688
- K834096 — IMPLANTABLE PULSE GENERATOR
- K833798 — OPTIMA MDT PULSE GENERATOR W/TELEMETRY
- K832914 — PRIMA-UNIPOLAR CARDIAC PULSE GENERAT
Data sourced from openFDA. This site is unofficial and independent of the FDA.