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
Market context for product code DXY
FDA has cleared devices under product code DXY between 1976 and 1999, filed by 48 applicant companies. No FDA device recalls reference this product code. Class III devices are high-risk and generally require premarket approval (PMA); 510(k) clearance under a Class III product code is limited to certain preamendments-type devices.
Clearances per year
last 15 years- 1999
- 1997
- 1996
- 1995
- 1994
- 1993
- 1992
- 1991
- 1990
- 1989
- 1988
- 1987
- 1986
- 1985
- 1984
Top applicants under product code DXY
Adverse events under product code DXY
product code DXY- Death
- 240
- Injury
- 2,328
- Malfunction
- 2,096
- Total
- 4,664
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DXY
1–100 of 461- K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A
- K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS
- K945627 — PIKOS LP 01, PIKOS LP E01
- K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION)
- K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION)
- K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01
- K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS
- K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024)
- K940039 — PELLETHANE 75D
- K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER
- K950751 — TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES
- K950210 — CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER
- K941937 — PIKOS E 01-B
- K932884 — MINIX/MINIX ST PULSE GENERATORS
- K923026 — PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER
- K923868 — CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER
- K930770 — MEDTRONIC MINIX & MINIX ST PULSE GENERATORS
- K920601 — ASTRA T2, ASTRA T4, ASTRA T6
- K920530 — INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG
- K920157 — SCHNEIDER 8 FR. STAMINA(TM) GUIDING CATHETER
- K914109 — PIKOS 01 & PIKOS E 01
- K905403 — MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER
- K913134 — MODEL 4220
- K912545 — MODEL 4205 PULSE GENERATOR SURGICAL EXTEN CABLE
- K905824 — MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE
- K911122 — 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS
- K905087 — TRIOS 02
- K903186 — OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE
- K904602 — MEDTRONIC MODEL 5301B TEST CABLE
- K904941 — MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE
- K904892 — VACUUM BAKE CYCLE
- K903919 — IMPLANTABLE PULSE DEVICES
- K903081 — NEOS (TM) 02 B PULSE GENERATOR
- K901535 — MODIFIED MEDTRONIC CLASSIX MODEL 8438 PULSE GENE.
- K902134 — MINIX, MINIX ST, NEW IC: L74
- K900622 — MODIFIED MODEL 5401B TEST CABLE
- K897116 — OPTIMA MPT MODEL 5281E AND MODEL 5282E
- K900461 — OPUS MODEL 4021, VVI, 5MM UNIPOLAR
- K896809 — MEDTRONIC SPECTRAX SXT MODEL 8423M PULSE GENERATOR
- K896184 — KALOS 05 PULSE GENERATOR
- K894239 — NANOS
- K894240 — NEOS 02
- K894494 — LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD
- K894065 — OPUS MODEL 4001
- K895495 — ADD'L LABELING TO MINIX MODELS AND MINIX ST MODELS
- K894267 — OPUS MODELS 4033 AND 4034
- K891231 — OPTIMA MPT AND SPT PACEMAKERS
- K884420 — HOME BLOOD PRESSURE KIT, ANEROID
- K894055 — MINIX 8341M AND MINIX ST 8331M PULSE GENERATORS
- K894185 — OPTIMA MPT SERIES III PACEMAKER, UNIPOLAR/BIPOLAR
- K885267 — VS-1 MODEL NUMBER 251K PULSE GENERATOR
- K890785 — ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE
- K884733 — AFP MODEL 262T PULSE GENERATOR
- K884411 — OPTIMA MPT AND SPT PACEMAKERS
- K883037 — UNILITH 3 MODELS 7580/7583/7680/7683
- K883750 — VENTRALITH I
- K883755 — MODIFIED SPECTRAX SX/SXT & PASYS/PASYS ST MODELS
- K884215 — MINIX 8340, 8341, 8342 MINIX-ST 8330, 8331
- K882391 — OPUS 3 PULSE GENERATORS MODELS 4003,4004,4023,4024
- K884023 — MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER
- K882427 — CARDIAC PACE. OPUS 4000 MODELS 4043/4044/4063/4066
- K883087 — PROLOG MP 658M PULSE GENERATOR
- K882474 — OPUS PULSE GENERATORS MODELS 2001, 2003 AND 2004
- K882476 — OPUS PULSE GENERATORS MODELS 3001, 3003 AND 3004
- K881904 — CHANGE TO CATHODE POWDER SPECIFICATION
- K881837 — OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D
- K881711 — VICOR MODELS 410B & 410D AND MODIFIED 410A PACEMA.
- K880898 — MULTICOR AND PACEMAKERS
- K880326 — MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS
- K880422 — MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER
- K880432 — VICOR PACER, MODEL 410A
- K873158 — MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS
- K874158 — CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK.
- K874394 — QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA.
- K872766 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- K872779 — PROLOG MP PULSE GENERATORS 658K AND 658T
- K873202 — VICOR, MODEL 410A
- K873528 — MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS
- K871992 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- K871866 — MEDTRONIC CLASSIX MODELS 8436/8437/8438
- K871861 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS
- K870142 — PINNACLE SR 8701 - UNIPOLAR & 8702 - BIPOLAR
- K865013 — ASTRA T2, T4 AND T6
- K863898 — MULTILITH 3 MODELS 1350, 3350, 1370, 3370
- K862226 — DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
- K860036 — EDP-20 PACEMAKER
- K862459 — MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE
- K863878 — TRIOS-M VS-1 PULSE GENERATOR
- K863879 — NEOS-M VS-1 PULSE GENERATOR
- K863365 — MODIFICATION OF STERILITY CYCLE PARAMETERS
- K863417 — CORDIS MULTICOR II MODEL 402D PACER
- K863582 — MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER)
- K863418 — MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE
- K862974 — ALTERNATE PACKAGE CONFIG. FOR IMPLANT. PULSE GEN.
- K854790 — CERYX PACEMAKER MODELS 114, 314 & 614
- K860921 — NEOS VS-1, PULSE GENERATOR
- K860922 — MIKROS, MIKROS VS-1, PULSE GENERATOR
- K860585 — ASTRA T2, T3, T4 & T6 MULTIPROGRAM PULSE GENERATOR
- K853771 — PINNACLE MULTI-PROGRAMMABLE PACING SYS
- K861719 — MODIFIED MODELS 8320/8322/8329/8316/8317/8318
Data sourced from openFDA. This site is unofficial and independent of the FDA.