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487 FDA 510(k) clearances · Product code

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RecordFirmDate
IMPLANTABLE ENDOCARDIAL PACING LEADS (K831997)Oscor, Inc.1983-10-20
BIOTRONIK DFH UNIPOLAR PE-60/4-DFH (K833106)Biotronik Sales, Inc.1983-10-20
BIOTRONIK N, BIPOLAR PEB-60/4-N (K833099)Biotronik Sales, Inc.1983-10-20
BIOTRONIK DN UNIPOLAR PE-60/4-DN & (K833098)Biotronik Sales, Inc.1983-10-19
BIOTRONIK D2K UNIPOLAR PE-60/4 (K833104)Biotronik Sales, Inc.1983-10-19
BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC (K833101)Biotronik Sales, Inc.1983-10-19
BIOTRONIK I-UNIPOLAR PE-60/2-13 (K833108)Biotronik Sales, Inc.1983-10-19
ELECTRODE LEADS 030-267 & 030-268 (K832110)Telectronics, Inc.1983-08-12
UNIPOLAR-E ENDOCARDIAL TINED LEAD (K832245)Cook Pacemaker Corp.1983-08-12
LIFELINE PACING LEADS #471-07 &09 (K832409)Intermedics, Inc.1983-08-12
MODEL F UNIPOLAR ENDOCARDIAL LEAD- (K832255)Cook Pacemaker Corp.1983-08-12
MEDTRONIC MODELS 4012 & 4512 (K832099)Medtronic Vascular1983-07-26
IMPLANTABLE CARDIAC PACING LEADS (K831767)Oscor, Inc.1983-07-26
CCS MODEL SJ-103 IMPLANTABLE ATRIAL (K831529)Cardiac Control Systems, Inc.1983-06-30
UNIPOLAR ATRIAL J PACING LEAD MODEL 869 (K831436)Pacesetter Systems1983-06-08
VENTRICULAR PACING LEADS MODELS 865/867 (K831435)Pacesetter Systems1983-06-08
TELECTRONICS #030-253 BIFURCATED (K831303)William C. Nealon1983-05-25
POROUS TIP ENDOCARDIAL LEAD (K830743)Daig Corp.1983-05-09
MODEL FF..D & FX..D PACEMAKER LEADS (K823896)Dr. Ing. P. Osypka, GmbH1983-04-30
MODEL MF..D & MX..D PACEMAKER LEADS (K823898)Oscor, Inc.1983-04-30
MODEL JY PACEMAKER LEAD - VARIOUS (K823889)Oscor, Inc.1983-04-30
MODEL MZ PACEMAKER LEAD-VARIOUS (K823893)Oscor, Inc.1983-04-30
MODEL SZ PACEMAKER LEAD-VARIOUS (K823892)Dr. Ing. P. Osypka, GmbH1983-04-30
MODEL RZ PACEMAKER LEAD VARIOUS (K823894)Dr. Ing. P. Osypka, GmbH1983-04-30
MODEL SF. D&SX.D PACEMAKER LEADS (K823897)Oscor, Inc.1983-04-30
MODEL RF. D&RX..D PACEMAKER LEADS (K823895)Oscor, Inc.1983-04-30
IMPLANTABLE PACING LEAD CCS MODEL SV-101 (K830828)Cardiac Control Systems, Inc.1983-04-28
LIFELINE ENDOCARDIAL PACING LEAD #479-05 (K830782)Intermedics, Inc.1983-04-18
VASCULAR PRODUCTS IMPLANTABLE PACING (K830950)Oscor, Inc.1983-04-18
MODEL KY PACEMAKER LEAD - VARIOUS (K823891)Oscor, Inc.1983-03-31
MODEL ZY PACEMAKER LEAD-VARIOUS (K823890)Oscor, Inc.1983-03-31
PACING LEAD #PMA F 860 (K830457)Ela Medical, Inc.1983-03-17
PACEMAKER ELECTRODE PERM. & TEMP (K830464)Daig Corp.1983-03-16
LIFELINE UNIPOLAR J-LEAD #483-05 (K830463)Intermedics, Inc.1983-02-28
LIFELINE -UNIPOLAR LEAD #487-05 (K823508)Intermedics, Inc.1983-01-14
ELECTRODE LEAD OF SILICONE ELASTOMETER (K823452)Telectronics, Inc.1983-01-08
ELECTRODE, PACEMAKER, PERMANENT (K823033)Pacesetter Systems1982-12-30
IMPLANTABLE PACING LEAD, TINED #3262 & (K823447)Vascular Products, Inc.1982-12-03
IMPLANTABLE PACING LEAD TINED #3390 & (K823448)Oscor, Inc.1982-12-03
PRODUCTS IMPLANTABLE PACING LEAD,TINED (K823446)Oscor, Inc.1982-12-03
MEDTRONIC MODELS 4011 & 4511 (K822781)Medtronic Vascular1982-11-30
COAXIAL BIPOLAR PACING ELECTRODE (K822239)Burditt & Calkins-Siemens-Elema1982-10-04
FASTPASS IMPLANTABLE ENDOCARD. PACING (K821947)Pacesetter Systems1982-08-06
POROUS SURFACED PLATINUM IRIDIUM (K821889)Cordis Corp.1982-08-06
MEDTRONIC #6993 (K820989)Medtronic Vascular1982-08-06
IMPLANTIBLE SUTURE SLEEVE (K820487)Intermedics, Inc.1982-04-16
BIOPOLAR TINED ENDOCARDIAL LEAD 403B/60 (K820767)Siemens Elema AB1982-04-09
STOCKERT CARDIAC PACING ELECTRODES (K812049)Stoeckert Instrumente1982-03-18
PERMANENT & TEMPORARY PACEMAKER ELECTR. (K820262)Diag Corp.1982-03-12
LASERPOR AP ATRIAL ENDOCARD. ELECTR. LD. (K820121)Telectronics, Inc.1982-02-12
PERMANENT ENDOCARD. UNIPOLAR TINED LEAD (K812905)Diag Corp.1982-02-04
INTERSEPT CARDIOTOMY RESERVOIR/FILTER (K813205)Extracorporeal Medical Specialities, Inc.1982-01-28
APC IMPLANTABLE PACING LEAD (K812830)American Pacemaker Corp.1982-01-18
APC IMPLANTABLE PACING LEADS (K812807)American Pacemaker Corp.1982-01-18
ATRIAL ENDOCARDIAL ELECTRODE LEAD J-TIP (K813134)Telectronics, Inc.1981-12-10
POLY-FLEX PACING LEADS (K813028)Intermedics, Inc.1981-12-10
PACEPATH IMPLANT. ENDOCARD. PACING LEAD (K810286)Pacesetter Systems1981-11-27
ELECTRODE, PACEMAKER, PERMANENT (K810139)Pacesetter Systems1981-11-27
INTERMEDICS POLYFLEX-MODEL 483-03 LEAD (K812990)Intermedics, Inc.1981-11-16
INTERMEDICS POLYFLEX-MODEL 493-03 LEAD (K812989)Intermedics, Inc.1981-11-16
INTERMEDICS POLYFLEX-MODEL 483-04 LEAD (K812991)Intermedics, Inc.1981-11-16
MODEL 841 ENDOCARDIAL TINED LEAD (K812816)Pacesetter Systems1981-10-29
MODEL 833 ENDOCARDIAL TINED LEAD (K812815)Pacesetter Systems1981-10-29
MEDTRONIC #4951 (K812599)Medtronic Vascular1981-10-23
ATRIAL ENDOCARDIAL ELECTRODE LEAD OF J (K811593)Telectronics, Inc.1981-10-13
INTERMEDICS POLY FLEX ENDOCARDIAL ATRIAL (K812245)Intermedics, Inc.1981-10-06
INTERMEDICS POLY FLEX EPICARDIAL SUTURE (K812221)Intermedics, Inc.1981-10-06
PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL (K812270)Diag Corp.1981-09-16
PACEPATH IMPLANTABLE ENDOCARD. PACING LD (K811200)Pacesetter Systems1981-08-13
TYPE FH ENDOCARDIAL LEAD (K810494)Biotronik Sales, Inc.1981-08-07
MODEL A UNIPOLAR ENDOCARDIAL LEAD (K811879)Cook Pacemaker Corp.1981-08-03
MODEL C UNIPOLAR ENDOCARDIAL LEAD (K811877)Cook Pacemaker Corp.1981-08-03
MODEL D BIPOLAR ENDOCARDIAL LEAD (K811876)Cook Pacemaker Corp.1981-08-03
MODEL B BIPOLAR ENDOCARDIAL LEAD (K811878)Cook Pacemaker Corp.1981-08-03
ENDOCARDIAL ELECTRODE (K810928)Vitatron Medical BV1981-07-02
CORDIS ENCOR PEWENOUS VENTRICULAR BIPOL (K811539)Cordis Corp.1981-07-01
INTERMEDICS POLY FLEX ENDOCARDIAL PACING (K811106)Intermedics, Inc.1981-05-27
APC IMPLANTABEL PACING LEAD, MODEL 3264 (K810399)American Pacemaker Corp.1981-05-15
APC IMPLANTABLE PACING LEAD-FLANGE #3260 (K810397)American Pacemaker Corp.1981-05-15
APC IMPLANTABLE PACING LEAD, MODEL 3266 (K810398)American Pacemaker Corp.1981-05-15
APC IMPLANTABLE PACING LEAD, TINED #3262 (K810396)American Pacemaker Corp.1981-05-15
TYPE YC ENDOCARDIAL LEAD (K810491)Biotronik Sales, Inc.1981-03-20
TYPE YR ENDOCARDIAL LEAD (K810492)Biotronik Sales, Inc.1981-03-20
TYPE N ENDOCARDIAL LEAD (K810493)Biotronik Sales, Inc.1981-03-20
CORDIS PERVENOUS ATRIAL LEAD (K810432)Cordis Corp.1981-03-13
ELECTRODE, PACEMAKER PERMANENT (K810582)Pacesetter Systems1981-03-13
TEMPORARY MYOCARDIAL PACING LEAD#6400 (K810333)Medtronic Vascular1981-03-13
POLY FLEX IMPLANTABLE PACING LEAD (K802295)Intermedics, Inc.1981-02-09
CORDIS MULTIFILAR PERVENOUS VENTRIC. LD (K810202)Cordis Corp.1981-02-05
PERM. ENDOCARDIAL UNIPOLAR WEDGE URETHAN (K802553)Daig Corp.1981-01-16
PERM. ENDOCARDIAL UNIPOLAR TINED/WEDGE (K802552)Daig Corp.1981-01-16
ENDOCARDIAL LEADS 414S & 515S (K802816)Siemens Elema AB1981-01-16
PERMANENT & TEMP. PACEMAKER ELECTRODE (K802547)Daig Corp.1981-01-16
IMPLANT. ENDOCARDIAL DISH TIP ELECT. LDS (K802413)Telectronics, Inc.1981-01-02
SIEMENS-ELEMA ENDOCARDIAL LEAD 402S (K803042)Siemens Elema AB1980-12-22
UNIPOLAR ENDOCARDIAL LASER DRILLED ELEC (K802968)Telectronics, Inc.1980-12-22
INTERMEDICS' LIFELINE TLE ENDOCARDIAL (K801172)Intermedics, Inc.1980-12-01
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002) (K801284)Medtronic Vascular1980-12-01
MEDTRONIC MODEL 6958 (K800870)Medtronic Vascular1980-11-13
POLYFLEX IMPLANTABLE PACING LEAD (K802293)Intermedics, Inc.1980-10-31
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