Cardiac Control Systems, Inc.
Mchenry, IL, US
Cardiac Control Systems, Inc. appears in FDA device records in Mchenry, IL. FDA records list 26 510(k) clearances between and , 30 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
- 26
- PMA records
- 30
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 26 510(k) clearances for Cardiac Control Systems, Inc. between 1983 and 1997. The busiest year on record is 1988, with 6. The most recent is 1997, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1983 | 2 |
| 1984 | 1 |
| 1985 | 4 |
| 1986 | 4 |
| 1987 | 2 |
| 1988 | 6 |
| 1989 | 1 |
| 1991 | 2 |
| 1993 | 1 |
| 1995 | 2 |
| 1997 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K971775 | INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 | LDF | Substantially Equivalent | |
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | DXY | Substantially Equivalent - Subject to Tracking Reg. | |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | DXY | Substantially Equivalent - Subject to Tracking Reg. | |
| K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | DXY | Substantially Equivalent | |
| K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | DXY | Substantially Equivalent | |
| K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | DXY | Substantially Equivalent | |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | DTG | Substantially Equivalent | |
| K884023 | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER | DXY | Substantially Equivalent | |
| K884024 | POLYSAFE(TM) IMPLANTABLE PACING LEAD | DTB | Substantially Equivalent | |
| K883015 | POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP | DTB | Substantially Equivalent | |
| K883016 | POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP | DTB | Substantially Equivalent | |
| K880326 | MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS | DXY | Substantially Equivalent | |
| K880422 | MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER | DXY | Substantially Equivalent | |
| K874158 | CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. | DXY | Substantially Equivalent | |
| K864601 | CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD | DTB | Substantially Equivalent | |
| K861009 | BIPOLAR CARDIAC PACEMAKER, MODEL 110 | DXY | Substantially Equivalent | |
| K853471 | CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA | DXY | Substantially Equivalent | |
| K853400 | CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK | DXY | Substantially Equivalent | |
| K853446 | POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 | DTB | Substantially Equivalent | |
| K853294 | CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA | DTB | Substantially Equivalent | |
| K851897 | CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD | DTD | Substantially Equivalent | |
| K852435 | CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA | DXY | Substantially Equivalent | |
| K850384 | CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER | DXY | Substantially Equivalent | |
| K834342 | CCS MODEL AV-102 IMPLANTABLE A-V DATA | DTB | Substantially Equivalent | |
| K831529 | CCS MODEL SJ-103 IMPLANTABLE ATRIAL | DTB | Substantially Equivalent | |
| K830828 | IMPLANTABLE PACING LEAD CCS MODEL SV-101 | DTB | 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