Biotronik Sales, Inc.
Mchenry, IL, US
Biotronik Sales, Inc. appears in FDA device records in Mchenry, IL. FDA records list 41 510(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
- 41
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 41 510(k) clearances for Biotronik Sales, Inc. between 1980 and 1988. The busiest year on record is 1985, with 9. The most recent is 1988, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1980 | 2 |
| 1981 | 5 |
| 1982 | 3 |
| 1983 | 7 |
| 1984 | 4 |
| 1985 | 9 |
| 1986 | 8 |
| 1987 | 2 |
| 1988 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K875199 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR | DTB | Substantially Equivalent | |
| K853194 | ERA-20 | DTE | Substantially Equivalent | |
| K860036 | EDP-20 PACEMAKER | DXY | Substantially Equivalent | |
| K863879 | NEOS-M VS-1 PULSE GENERATOR | DXY | Substantially Equivalent | |
| K863878 | TRIOS-M VS-1 PULSE GENERATOR | DXY | Substantially Equivalent | |
| K863480 | BIOTRONIK PERMANENT PACEMAKER ELECTRODE | DTB | Substantially Equivalent | |
| K860921 | NEOS VS-1, PULSE GENERATOR | DXY | Substantially Equivalent | |
| K860922 | MIKROS, MIKROS VS-1, PULSE GENERATOR | DXY | Substantially Equivalent | |
| K853567 | DJP UNIPOLAR | DTB | Substantially Equivalent | |
| K853566 | DJ UNIPOLAR | DTB | Substantially Equivalent | |
| K853568 | DNR UNIPOLAR | DTB | Substantially Equivalent | |
| K853058 | NEOS - M ABP | DXY | Substantially Equivalent | |
| K853057 | TRIOS - M | DXY | Substantially Equivalent | |
| K844842 | NEOS-LP PULSE GENERATOR | DXY | Substantially Equivalent | |
| K844841 | KALOS-04 PULSE GENERATOR | DXY | Substantially Equivalent | |
| K844812 | NEOS - PULSE GENERATOR | DXY | Substantially Equivalent | |
| K844795 | NEOS-M PULSE GENERATOR | DXY | Substantially Equivalent | |
| K844794 | LEPTOS PULSE GENERATOR | DXY | Substantially Equivalent | |
| K841451 | BIOTRONIK DY-UNIPOLAR | DTD | Substantially Equivalent | |
| K841450 | BIOTRONIK DNP UNIPOLAR | DTD | Substantially Equivalent | |
| K841633 | NEOS LP | DXY | Substantially Equivalent | |
| K841635 | LEPTOS | DXY | Substantially Equivalent | |
| K841950 | PULSE GENERATOR KALOS-04 | DXY | Substantially Equivalent | |
| K841636 | NEOS M | DXY | Substantially Equivalent | |
| K833106 | BIOTRONIK DFH UNIPOLAR PE-60/4-DFH | DTB | Substantially Equivalent | |
| K833099 | BIOTRONIK N, BIPOLAR PEB-60/4-N | DTB | Substantially Equivalent | |
| K833108 | BIOTRONIK I-UNIPOLAR PE-60/2-13 | DTB | Substantially Equivalent | |
| K833104 | BIOTRONIK D2K UNIPOLAR PE-60/4 | DTB | Substantially Equivalent | |
| K833101 | BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC | DTB | Substantially Equivalent | |
| K833098 | BIOTRONIK DN UNIPOLAR PE-60/4-DN & | DTB | Substantially Equivalent | |
| K830862 | NEDS-01 & EPR-500 | DXY | Substantially Equivalent | |
| K822907 | KALOS-03 BIPOLAR | DXY | Substantially Equivalent | |
| K821073 | PULSE GENERATOR | DXY | Substantially Equivalent | |
| K820774 | IMPLANTABLE, MULTIPROGRAMMABLE | DXY | Substantially Equivalent | |
| K812218 | KALOS-03 | DXY | Substantially Equivalent | |
| K810494 | TYPE FH ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K810493 | TYPE N ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K810492 | TYPE YR ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K810491 | TYPE YC ENDOCARDIAL LEAD | DTB | Substantially Equivalent | |
| K800376 | EPR-200 PROGRAMMER MODEL 010 | KRG | Substantially Equivalent | |
| K800375 | NOMOS-01 PULSE GENERATOR | DXY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
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