Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiac Control Systems, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
76 daysmedian FDA review time
199 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K971775 | INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 | Cardiac Control Systems, Inc. | 1997-12-29 | 230 | 0 |
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | Cardiac Control Systems, Inc. | 1995-05-15 | 146 | 0 |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACE | Cardiac Control Systems, Inc. | 1995-05-03 | 104 | 0 |
| K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | Cardiac Control Systems, Inc. | 1993-05-14 | 284 | 0 |
| K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | Cardiac Control Systems, Inc. | 1991-05-16 | 136 | 0 |
| K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | Cardiac Control Systems, Inc. | 1991-01-03 | 63 | 0 |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | Cardiac Control Systems, Inc. | 1989-09-26 | 42 | 0 |
| K884023 | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER | Cardiac Control Systems, Inc. | 1988-10-17 | 25 | 0 |
| K884024 | POLYSAFE(TM) IMPLANTABLE PACING LEAD | Cardiac Control Systems, Inc. | 1988-10-14 | 22 | 0 |
| K883015 | POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP | Cardiac Control Systems, Inc. | 1988-10-06 | 79 | 0 |
| K883016 | POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP | Cardiac Control Systems, Inc. | 1988-09-16 | 59 | 0 |
| K880326 | MAESTRO(R) MODELS 115, 118, 215 AND 218 PACEMAKERS | Cardiac Control Systems, Inc. | 1988-04-11 | 76 | 0 |
| K880422 | MAESTRO(R) MODEL 119, SINGLE-CHAMBER PACEMAKER | Cardiac Control Systems, Inc. | 1988-03-31 | 59 | 0 |
| K874158 | CCS IMPLANTABLE MAESTRO(R) SERIES 100/200 PACEMAK. | Cardiac Control Systems, Inc. | 1987-12-29 | 77 | 0 |
| K864601 | CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD | Cardiac Control Systems, Inc. | 1987-01-06 | 43 | 0 |
| K861009 | BIPOLAR CARDIAC PACEMAKER, MODEL 110 | Cardiac Control Systems, Inc. | 1986-04-23 | 36 | 0 |
| K853471 | CCS IMPLANTABLE MAESTRO 106/206/210 CARDIAC PACEMA | Cardiac Control Systems, Inc. | 1986-02-24 | 189 | 0 |
| K853400 | CCS IMPLANTABLE MAESTRO SERIES 200 CARDIAC PACEMAK | Cardiac Control Systems, Inc. | 1986-02-24 | 199 | 0 |
| K853446 | POLYSAFE CCS TRIFIX ENDOCARDIAL PACING LEAD SV-107 | Cardiac Control Systems, Inc. | 1986-01-13 | 150 | 0 |
| K853294 | CCS MODEL BV-114 IMPLANTABLE ENDOCARDIAL BIPOLARPA | Cardiac Control Systems, Inc. | 1985-12-04 | 110 | 0 |
| K851897 | CCS MODEL AV-106 IMPLANTABLE A-V DATA LEAD | Cardiac Control Systems, Inc. | 1985-08-09 | 101 | 0 |
| K852435 | CCS IMPLANTABLE MAESTRO SERIES 100 CARDIAC PACEMA | Cardiac Control Systems, Inc. | 1985-08-06 | 57 | 0 |
| K850384 | CCS IMPLANTABLE MAESTRO SERIES 100-HEART PACEMAKER | Cardiac Control Systems, Inc. | 1985-03-21 | 48 | 0 |
| K834342 | CCS MODEL AV-102 IMPLANTABLE A-V DATA | Cardiac Control Systems, Inc. | 1984-02-04 | 54 | 0 |
| K831529 | CCS MODEL SJ-103 IMPLANTABLE ATRIAL | Cardiac Control Systems, Inc. | 1983-06-30 | 49 | 0 |
| K830828 | IMPLANTABLE PACING LEAD CCS MODEL SV-101 | Cardiac Control Systems, Inc. | 1983-04-28 | 43 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda