Intermedics, Inc.
Mchenry, IL, US
Intermedics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 211 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 211
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 211FDA records hold 211 510(k) clearances for Intermedics, Inc. between 1977 and 1996. The busiest year on record is 1985, with 39. The most recent is 1996, with 6.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 3 |
| 1978 | 9 |
| 1979 | 24 |
| 1980 | 13 |
| 1981 | 31 |
| 1982 | 9 |
| 1983 | 15 |
| 1984 | 9 |
| 1985 | 39 |
| 1986 | 24 |
| 1987 | 11 |
| 1988 | 7 |
| 1989 | 3 |
| 1991 | 4 |
| 1992 | 1 |
| 1993 | 2 |
| 1995 | 1 |
| 1996 | 6 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K954610 | MODEL 430-07 ENDOCARDIAL PACING LEAD | DTB | Substantially Equivalent - Subject to Tracking & PMS | |
| K955122 | INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K962174 | BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K955550 | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K960281 | IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K954719 | INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD | DTB | Substantially Equivalent - Subject to Tracking Reg. | |
| K933278 | INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 | KRG | Substantially Equivalent | |
| K922042 | CARDIFIX ENDOCARDIAL PACING LEAD | DTB | Unknown | |
| K922972 | MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD | DTB | Unknown | |
| K920530 | INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG | DXY | Substantially Equivalent | |
| K912235 | MODELS 432-03 & 433-03 IMPLANT ENDOCARD PAC LEAD | DTB | Substantially Equivalent | |
| K911122 | 8MM QUANTUM PULSE/SUPRIMA II PULSE GENERATORS | DXY | Substantially Equivalent | |
| K903948 | INTERMEDICS MODEL 431-11 IMPLANT ENDOCARD PAC LEAD | DTB | Substantially Equivalent | |
| K902672 | INTERMEDICS 430-07 BIPOL IMPLANT ENDOCARD PAC LEAD | DTB | Substantially Equivalent | |
| K894718 | ADAPTAID(TM) ADAPTER SLEEVE MODEL 366-33 | DTD | Substantially Equivalent | |
| K890412 | MODELS 430-07 & 431-07 IMPLANTABLE PACING LEADS | DTB | Substantially Equivalent | |
| K890411 | MODELS 432-03 & 433-03 IMPLANTABLE PACING LEADS | DTB | Substantially Equivalent | |
| K883602 | BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD | DTB | Substantially Equivalent | |
| K875178 | MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | DTB | Substantially Equivalent | |
| K875100 | MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | DTB | Substantially Equivalent | |
| K872126 | MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD | DTB | Substantially Equivalent | |
| K880551 | MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K874531 | POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD | DTB | Substantially Equivalent | |
| K874930 | MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER | DTB | Substantially Equivalent | |
| K873921 | MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE | DTB | Substantially Equivalent | |
| K874394 | QUANTUM(R) MODELS 253-19V & 254-20V PULSE GENERA. | DXY | Substantially Equivalent | |
| K873528 | MODIFIED MODELS 253-19 & 254-20 QUANTUM GENERATORS | DXY | Substantially Equivalent | |
| K872230 | MODEL 366-29 ADAPTAID(TM) ADAPTER SLEEVE | DBT | Substantially Equivalent | |
| K871580 | IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01 | DTB | Substantially Equivalent | |
| K871625 | MODEL 366-12 ADAPTAID (TM) STEP-DOWN ADAPTER | DTB | Substantially Equivalent | |
| K870357 | ELECTRODE, PACEMAKER, PERMANENT & TEMPORARY | DTB | Substantially Equivalent | |
| K870948 | MODEL 435-03 SIDE HOOK IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K864326 | MODEL 366-13 ADAPTAID STEP DOWN ADAPTER | DTB | Substantially Equivalent | |
| K864738 | MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP | DTB | Substantially Equivalent | |
| K862051 | MODEL 436-01 BIOPORE IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K864564 | MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K864428 | MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER | DTB | Substantially Equivalent | |
| K864287 | MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K864002 | MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K864048 | MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER | DTB | Substantially Equivalent | |
| K864047 | MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER | DTB | Substantially Equivalent | |
| K863781 | MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K863418 | MODEL 352-01 SILICONE RUBBER ISOLATION SLEEVE | DXY | Substantially Equivalent | |
| K862054 | MODEL 430-01 BIOPORE IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K862053 | MODEL 432-01 BIOPORE IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K862259 | MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K862258 | MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K862257 | MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K862052 | MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K862276 | MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- DSACable, Transducer And Electrode, Patient, (Including Connector)
- JOSElectrode, Electrosurgical
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- DBTFactor Xiii A, S, Antigen, Antiserum, Control
- DTRHeat-Exchanger, Cardiopulmonary Bypass
- DXYImplantable Pacemaker Pulse-Generator
- HLMInstrument, Measuring, Lens, Ac-Powered
- DYBIntroducer, Catheter
- KFJMaterials, Repair Or Replacement, Pacemaker
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- DTDPacemaker Lead Adaptor
- DTBPermanent Pacemaker Electrode
- KRGProgrammer, Pacemaker
- DTEPulse-Generator, Pacemaker, External
- FRNPump, Infusion
- GDXScalpel, One-Piece
- IPFStimulator, Muscle, Powered
- ETNStimulator, Nerve
- BXNStimulator, Nerve, Battery-Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- DXHTransmitters And Receivers, Electrocardiograph, Telephone
- DRGTransmitters And Receivers, Physiological Signal, Radiofrequency
- HPSUnit, Cryophthalmic
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain