Company ยท US
Biotronik Sales, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1988. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 18, 1988 | K875199 | NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR Biotronik Sales, Inc. | DTB |
| Mar 11, 1987 | K853194 | ERA-20 Biotronik Sales, Inc. | DTE |
| Jan 12, 1987 | K860036 | EDP-20 PACEMAKER Biotronik Sales, Inc. | DXY |
| Dec 10, 1986 | K863879 | NEOS-M VS-1 PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Dec 10, 1986 | K863878 | TRIOS-M VS-1 PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Sep 23, 1986 | K863480 | BIOTRONIK PERMANENT PACEMAKER ELECTRODE Biotronik Sales, Inc. | DTB |
| Aug 8, 1986 | K860921 | NEOS VS-1, PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Aug 4, 1986 | K860922 | MIKROS, MIKROS VS-1, PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| May 7, 1986 | K853567 | DJP UNIPOLAR Biotronik Sales, Inc. | DTB |
| May 7, 1986 | K853566 | DJ UNIPOLAR Biotronik Sales, Inc. | DTB |
| Jan 15, 1986 | K853568 | DNR UNIPOLAR Biotronik Sales, Inc. | DTB |
| Sep 13, 1985 | K853058 | NEOS - M ABP Biotronik Sales, Inc. | DXY |
| Sep 12, 1985 | K853057 | TRIOS - M Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844842 | NEOS-LP PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844841 | KALOS-04 PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844812 | NEOS - PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844795 | NEOS-M PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 18, 1985 | K844794 | LEPTOS PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Feb 7, 1985 | K841451 | BIOTRONIK DY-UNIPOLAR Biotronik Sales, Inc. | DTD |
| Feb 7, 1985 | K841450 | BIOTRONIK DNP UNIPOLAR Biotronik Sales, Inc. | DTD |
| Aug 6, 1984 | K841633 | NEOS LP Biotronik Sales, Inc. | DXY |
| Aug 3, 1984 | K841635 | LEPTOS Biotronik Sales, Inc. | DXY |
| Jun 25, 1984 | K841950 | PULSE GENERATOR KALOS-04 Biotronik Sales, Inc. | DXY |
| Jun 25, 1984 | K841636 | NEOS M Biotronik Sales, Inc. | DXY |
| Oct 20, 1983 | K833106 | BIOTRONIK DFH UNIPOLAR PE-60/4-DFH Biotronik Sales, Inc. | DTB |
| Oct 20, 1983 | K833099 | BIOTRONIK N, BIPOLAR PEB-60/4-N Biotronik Sales, Inc. | DTB |
| Oct 19, 1983 | K833108 | BIOTRONIK I-UNIPOLAR PE-60/2-13 Biotronik Sales, Inc. | DTB |
| Oct 19, 1983 | K833104 | BIOTRONIK D2K UNIPOLAR PE-60/4 Biotronik Sales, Inc. | DTB |
| Oct 19, 1983 | K833101 | BIOTRONIK DYC, UNIPOLAR PE-60/4-DYC Biotronik Sales, Inc. | DTB |
| Oct 19, 1983 | K833098 | BIOTRONIK DN UNIPOLAR PE-60/4-DN & Biotronik Sales, Inc. | DTB |
| May 25, 1983 | K830862 | NEDS-01 & EPR-500 Biotronik Sales, Inc. | DXY |
| Nov 1, 1982 | K822907 | KALOS-03 BIPOLAR Biotronik Sales, Inc. | DXY |
| May 7, 1982 | K821073 | PULSE GENERATOR Biotronik Sales, Inc. | DXY |
| Apr 9, 1982 | K820774 | IMPLANTABLE, MULTIPROGRAMMABLE Biotronik Sales, Inc. | DXY |
| Oct 13, 1981 | K812218 | KALOS-03 Biotronik Sales, Inc. | DXY |
| Aug 7, 1981 | K810494 | TYPE FH ENDOCARDIAL LEAD Biotronik Sales, Inc. | DTB |
| Mar 20, 1981 | K810493 | TYPE N ENDOCARDIAL LEAD Biotronik Sales, Inc. | DTB |
| Mar 20, 1981 | K810492 | TYPE YR ENDOCARDIAL LEAD Biotronik Sales, Inc. | DTB |
| Mar 20, 1981 | K810491 | TYPE YC ENDOCARDIAL LEAD Biotronik Sales, Inc. | DTB |
| Apr 21, 1980 | K800376 | EPR-200 PROGRAMMER MODEL 010 Biotronik Sales, Inc. | KRG |
| Apr 16, 1980 | K800375 | NOMOS-01 PULSE GENERATOR Biotronik Sales, Inc. | DXY |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||