FDA Product Code
FDA Product Code DXY — Clearance Directory
- Device Class
- Class III
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.3610
510(k) Clearances — 461 records · page 2 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K861422 | PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY | Pacesetter Systems | 1986-06-26 | Traditional | PDF ↗ |
| K862038 | MODIFY LABEL/SPECTRAX S & SX IMPLANT PULSE GENER | Medtronic Vascular | 1986-06-17 | Traditional | PDF ↗ |
| K862071 | MODIFIED LABEL FOR/SPECTRAX SXT IMPLANT. PULSE GEN | Medtronic Vascular | 1986-06-17 | Traditional | PDF ↗ |
| K862037 | MODIFY LABEL/PASYS & MOD 8316/17/18 IMPLAN PUL GEN | Medtronic Vascular | 1986-06-17 | Traditional | PDF ↗ |
| K860573 | IMPLANT PROG PULSE GENERATOR, UNIPOLAR & BIPOLAR | Telectronics, Inc. | 1986-05-28 | Traditional | PDF ↗ |
| K861559 | SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS | Cook Pacemaker Corp. | 1986-05-09 | Traditional | PDF ↗ |
| K861140 | PROGRAMALITH III PULSE GENERATOR | Pacesetter Systems | 1986-05-02 | Traditional | PDF ↗ |
| K861009 | BIPOLAR CARDIAC PACEMAKER, MODEL 110 | Cardiac Control Systems, Inc. | 1986-04-23 | Traditional | PDF ↗ |
| K852973 | UNILITH 2 PULSE GENERATORS #7550, 7552, 7760, 7762 | Ela Medical, Inc. | 1986-03-31 | Traditional | PDF ↗ |
| K855147 | MEDTRONIC MODELS 8316,8317,8318 PULSE GENERATORS | Medtronic Vascular | 1986-03-17 | Traditional | PDF ↗ |
| K855081 | PHOENIX MODELS 250/251 PULSE GENERATORS | Pacesetter Systems | 1986-03-07 | Traditional | PDF ↗ |
| K854482 | ALTERNATE STERILE PKG IMPLANTABLE PULSE GENERATORS | Medtronic Vascular | 1986-02-28 | Traditional | PDF ↗ |
| K860466 | MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. | Cook Pacemaker Corp. | 1986-02-24 | Traditional | PDF ↗ |
| K860202 | MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. | Cook Pacemaker Corp. | 1986-02-24 | Traditional | PDF ↗ |
| K853471 | CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA | Cardiac Control Systems, Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K853400 | CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK | Cardiac Control Systems, Inc. | 1986-02-24 | Traditional | PDF ↗ |
| K855171 | TELEMETRY WAND MODEL | Cardiac Pacemakers, Inc. | 1986-01-22 | Traditional | PDF ↗ |
| K854560 | IMPLANTABLE PROGRAMMABLE PULSE GENERATOR | Telectronics, Inc. | 1986-01-16 | Traditional | PDF ↗ |
| K851968 | CORDIS MULTICOR ST, MODEL 350A | Cordis Corp. | 1986-01-14 | Traditional | PDF ↗ |
| K852641 | ORION 40 CARDIAC STIMULATOR & PMP 200 PROGRAMMER | Sorin Biomedica, Fiat, USA, Inc. | 1986-01-14 | Traditional | PDF ↗ |
| K854195 | PROGRAMALITH III MODELS 238 & 239 | Pacesetter Systems | 1986-01-07 | Traditional | PDF ↗ |
| K854919 | BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY | Cook Pacemaker Corp. | 1985-12-19 | Traditional | PDF ↗ |
| K854214 | MULTICOR II 402B & 402C MULTIPROGRAM. CARDIAC PACE | Cordis Corp. | 1985-12-03 | Traditional | PDF ↗ |
| K851365 | SORIN BIOMEDICA ORION 30/A CARDIAC STIMULATOR & PM | Sorin Biomedica, Fiat, USA, Inc. | 1985-12-03 | Traditional | PDF ↗ |
| K854132 | COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS | Cook Pacemaker Corp. | 1985-12-03 | Traditional | PDF ↗ |
| K852340 | SUPRIMA MODEL 254-24 | Intermedics, Inc. | 1985-11-08 | Traditional | PDF ↗ |
| K852339 | SUPRIMA MODEL 254-22 | Intermedics, Inc. | 1985-11-08 | Traditional | PDF ↗ |
| K852748 | CORDIS MODELS 336A,336B,337A & 334 CARDIAC PACEMAK | Cordis Corp. | 1985-11-01 | Traditional | PDF ↗ |
| K852688 | MEDTRONICS MODELS 8320/8322/8329 | Medtronic Vascular | 1985-11-01 | Traditional | PDF ↗ |
| K854143 | BATTERY INSULATOR FOR USE W/IMPLANTABLE PACEMAKERS | Telectronics, Inc. | 1985-11-01 | Traditional | PDF ↗ |
| K853651 | COOK PACEMAKER 33IT R UNIPOLAR CARDIAC PULSE GENER | Cook Pacemaker Corp. | 1985-10-23 | Traditional | PDF ↗ |
| K853590 | COOK PACEMAKER CORP. 327T, SERIES R UNIPOLAR CARDI | Cook Pacemaker Corp. | 1985-10-23 | Traditional | PDF ↗ |
| K853058 | NEOS - M ABP | Biotronik Sales, Inc. | 1985-09-13 | Traditional | PDF ↗ |
| K853206 | IMPLANT PROGRAM CARDIAC PULSE GEN W/MOD SET SCREW | Telectronics, Inc. | 1985-09-12 | Traditional | PDF ↗ |
| K853057 | TRIOS - M | Biotronik Sales, Inc. | 1985-09-12 | Traditional | PDF ↗ |
| K853425 | CARIO-PACE DURAPULSE P101 COATED PULSE GENERATOR | Cardio-Pace Medical, Inc. | 1985-08-19 | Traditional | PDF ↗ |
| K852435 | CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA | Cardiac Control Systems, Inc. | 1985-08-06 | Traditional | PDF ↗ |
| K853034 | #335-01 SILIC RUB ISOLA SLEEVE FOR INT #281-03 SIZ | Intermedics, Inc. | 1985-07-25 | Traditional | PDF ↗ |
| K853017 | ELA MEDICAL CARDIAC PACEMAKERS MULTIL 2 #1251&2251 | Ela Medical, Inc. | 1985-07-25 | Traditional | PDF ↗ |
| K852431 | SUPRIMA II MODEL 254-26 | Intermedics, Inc. | 1985-07-19 | Traditional | PDF ↗ |
| K852430 | SUPRIMA II MODEL 253-23 | Intermedics, Inc. | 1985-07-17 | Traditional | PDF ↗ |
| K852432 | SUPRIMA II MODEL 254-28 | Intermedics, Inc. | 1985-07-17 | Traditional | PDF ↗ |
| K851420 | MULTICOR S, MODELS 330A/331A | Cordis Corp. | 1985-06-21 | Traditional | PDF ↗ |
| K844360 | CORDIS MULTICOR S 330A & 331A CARDIAC PACEMAKERS | Cordis Corp. | 1985-06-18 | Traditional | PDF ↗ |
| K851417 | MULTICOR GAMMA MODELS 336/337 | Cordis Corp. | 1985-06-11 | Traditional | PDF ↗ |
| K851419 | MULTICOR GAMMA 402 SERIES PACER | Cordis Corp. | 1985-06-11 | Traditional | PDF ↗ |
| K851418 | OMNI-ATRICOR MODEL 308A | Cordis Corp. | 1985-06-11 | Traditional | PDF ↗ |
| K851416 | STANICOR GAMMA 333B/334A | Cordis Corp. | 1985-06-11 | Traditional | PDF ↗ |
| K851699 | COOK PACEMAKER CORP. 332T BIPOLAR CARDIAC PULSE GE | Cook Pacemaker Corp. | 1985-05-16 | Traditional | PDF ↗ |
| K851861 | PROGRAMALITH III MODEL 249 PULSE GENERATOR | Pacesetter Systems | 1985-05-16 | Traditional | PDF ↗ |
| K850464 | PROGRAMALITH III 240 PULSE GENERATOR | Pacesetter Systems | 1985-05-15 | Traditional | PDF ↗ |
| K844842 | NEOS-LP PULSE GENERATOR | Biotronik Sales, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844795 | NEOS-M PULSE GENERATOR | Biotronik Sales, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844841 | KALOS-04 PULSE GENERATOR | Biotronik Sales, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844812 | NEOS - PULSE GENERATOR | Biotronik Sales, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K844794 | LEPTOS PULSE GENERATOR | Biotronik Sales, Inc. | 1985-04-18 | Traditional | PDF ↗ |
| K851081 | IMPLANTABLE PROGRAM-CARDIAC PULSE GEN-OPTIMA MP II | Telectronics, Inc. | 1985-04-04 | Traditional | PDF ↗ |
| K850252 | QMPLANTABLE PROGRAM. CARDIAC PULSE GEN. W/TELEMETR | Telectronics, Inc. | 1985-04-04 | Traditional | PDF ↗ |
| K850651 | PROGRAMALITH III-3 MODEL 231 PULSE GENERATOR | Pacesetter Systems | 1985-04-01 | Traditional | PDF ↗ |
| K850384 | CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER | Cardiac Control Systems, Inc. | 1985-03-21 | Traditional | PDF ↗ |
| K842051 | EKG TRANSMITTER MODEL 5134 | Instromedix, Inc. | 1985-03-01 | Traditional | PDF ↗ |
| K850656 | COOK 331T UNIPOLAR CARDIAC PULSE GENERATOR W/TELEM | Cook Pacemaker Corp. | 1985-03-01 | Traditional | PDF ↗ |
| K844793 | SUPRIMA 253-21 IMPLANTABLE PULSE GENERATOR | Intermedics, Inc. | 1985-02-08 | Traditional | PDF ↗ |
| K844958 | MEDTRONIC MODELS 8432/8433/8434 - PACEMAKER PULSE | Medtronic Vascular | 1985-02-08 | Traditional | PDF ↗ |
| K844957 | MEDTRONIC MODEL 8436 -PACEMAKER PULSE GENERATOR | Medtronic Vascular | 1985-02-08 | Traditional | PDF ↗ |
| K842193 | MULTILITH PULSE GENERATORS, 1141 & 2141 | Ela Medical, Inc. | 1985-01-10 | Traditional | PDF ↗ |
| K844334 | VIVALITH II 301 PULSE GENERATOR | Pacesetter Systems | 1985-01-10 | Traditional | PDF ↗ |
| K841225 | PULSE GENERATOR 689, 689B & 689L | Siemens Elema AB | 1984-12-03 | Traditional | PDF ↗ |
| K841230 | PULSE GENERATOR 686, 686B 686L | Siemens Elema AB | 1984-12-03 | Traditional | PDF ↗ |
| K841232 | PULSE GENERATOR 696, 696B & 696L | Siemens Elema AB | 1984-12-03 | Traditional | PDF ↗ |
| K842220 | MULTILITH 2 PULSE GENERATOR 1141 & 2141 | Ela Medical, Inc. | 1984-11-29 | Traditional | PDF ↗ |
| K842473 | IMPLANTABLE PROGRAMMABLE PULSE GENERAT | Telectronics, Inc. | 1984-10-26 | Traditional | PDF ↗ |
| K842394 | ASTRA 2, ASTRA 3, 4 & 6 | Cardiac Pacemakers, Inc. | 1984-10-17 | Traditional | PDF ↗ |
| K843837 | MEDTRONIC 5984-5984LP-5985 | Medtronic Vascular | 1984-10-17 | Traditional | PDF ↗ |
| K843089 | MEDTRONIC 8437/8438 | Medtronic Vascular | 1984-08-29 | Traditional | PDF ↗ |
| K841633 | NEOS LP | Biotronik Sales, Inc. | 1984-08-06 | Traditional | PDF ↗ |
| K841635 | LEPTOS | Biotronik Sales, Inc. | 1984-08-03 | Traditional | PDF ↗ |
| K840748 | LITHIUM PACEMAKER 811-811L & 811XL | Omikron Scientific, Ltd. | 1984-08-03 | Traditional | PDF ↗ |
| K841928 | COOK PACEMAKER 215 UNIPOLAR CARDIAC- | Cook Pacemaker Corp. | 1984-07-11 | Traditional | PDF ↗ |
| K841983 | COOK PACEMAKER 216 BIPOLAR CARDIAC - | Cook Pacemaker Corp. | 1984-07-11 | Traditional | PDF ↗ |
| K841233 | PULSE GENERATOR 678L | Siemens Elema AB | 1984-07-06 | Traditional | PDF ↗ |
| K842081 | COOK PACEMAKER CORP. 115 UNIPOLAR CARDI | Cook Pacemaker Corp. | 1984-07-06 | Traditional | PDF ↗ |
| K841231 | PULSE GENERATOR 688B & 688L | Siemens Elema AB | 1984-06-26 | Traditional | PDF ↗ |
| K841226 | PULSE GENERATOR 728, 728B & 728L | Siemens Elema AB | 1984-06-26 | Traditional | PDF ↗ |
| K841228 | PULSE GENERATOR 718B & 718L | Siemens Elema AB | 1984-06-26 | Traditional | PDF ↗ |
| K841229 | PULSE GENERATOR 698, 698B & 698L | Siemens Elema AB | 1984-06-25 | Traditional | PDF ↗ |
| K841950 | PULSE GENERATOR KALOS-04 | Biotronik Sales, Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K841636 | NEOS M | Biotronik Sales, Inc. | 1984-06-25 | Traditional | PDF ↗ |
| K841404 | PRIMA 236-02 NONPROGRAMMABLE CARDIAC | Intermedics, Inc. | 1984-05-30 | Traditional | PDF ↗ |
| K841074 | CARDIAC PULSE GENERATOR 254-18 | Intermedics, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K841075 | CARCIAC PULSE GENERATOR 254-20 | Intermedics, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K840737 | IMPLANTABLE PROGRAMMABLE PULSE GENER | Telectronics, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K841073 | QUANTUM, UNIPOLAR, MULTI-PROGRAMMABLE | Intermedics, Inc. | 1984-05-16 | Traditional | PDF ↗ |
| K840701 | PACEMAKER 147 VVI-THE OPTINIA | Telectronics, Inc. | 1984-05-02 | Traditional | PDF ↗ |
| K833427 | IMPLANTABLE BIPOLAR CARDIAC PULSE GEN | Telectronics, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K833428 | IMPLANTABLE UNIPOLAR CARDIAC PULSE GEN | Telectronics, Inc. | 1984-02-10 | Traditional | PDF ↗ |
| K833519 | PULSE GENERATOR MODEL 688 | Burditt & Calkins-Siemens-Elema | 1984-01-30 | Traditional | PDF ↗ |
| K834096 | IMPLANTABLE PULSE GENERATOR | Intermedics, Inc. | 1983-12-16 | Traditional | PDF ↗ |
| K833798 | OPTIMA MDT PULSE GENERATOR W/TELEMETRY | Telectronics, Inc. | 1983-12-01 | Traditional | PDF ↗ |
| K832914 | PRIMA-UNIPOLAR CARDIAC PULSE GENERAT | Intermedics, Inc. | 1983-11-14 | Traditional | PDF ↗ |
Product code DXY · Class III · Cardiovascular. Data: openFDA.