Cardiac Control Systems, Inc.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Cardiac Control Systems, Inc.” (first 1983, latest 1997), plus 2 PMA decisions, across 6 product codes in 1 review panel. Median 510(k) review time under this name: 70 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DXY | Implantable Pacemaker Pulse-Generator | 15 | 14 |
| DTB | Permanent Pacemaker Electrode | 9 | 9 |
| DTD | Pacemaker Lead Adaptor | 1 | 1 |
| DTG | Magnet, Test, Pacemaker | 1 | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
| LWP | Implantable Pulse Generator, Pacemaker (Non-Crt) | 1 | 0 |
Review panels
- Cardiovascular (28)
Most recent Cardiac Control Systems, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K971775 | INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 | LDF | 1997-12-29 | 230 |
| K946188 | CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER | DXY | 1995-05-15 | 146 |
| K950210 | CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER | DXY | 1995-05-03 | 104 |
| K923868 | CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER | DXY | 1993-05-14 | 284 |
| K905824 | MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE | DXY | 1991-05-16 | 136 |
| K904941 | MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE | DXY | 1991-01-03 | 63 |
| K895110 | MAESTRO PACEMAKER TEST MAGNET | DTG | 1989-09-26 | 42 |
| K884023 | MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER | DXY | 1988-10-17 | 25 |
| K884024 | POLYSAFE(TM) IMPLANTABLE PACING LEAD | DTB | 1988-10-14 | 22 |
| K883015 | POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP | DTB | 1988-10-06 | 79 |
16 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P890039 | PMA | MASTRO SAVVI SERIES 300 VDD PACING SYSTEM | 1990-09-25 |
| P860027 | PMA | MAESTRO SERIES 500 P.G. MODELS 501, 505, 509 | 1987-02-27 |
Recalls
openFDA lists no recalls under a recalling firm named Cardiac Control Systems, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Cardiac Control Systems, Inc. (a text match, not an official crosswalk):
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via LWP)
- C1820 — Generator, neurostimulator (implantable), with rechargeable battery and charging system (via DXY)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Cardiac Pacemakers, Inc. (76 510(k)s)
- Cardiac Science Corporation (21 510(k)s)
- Cardiac Resucitator Corp. (17 510(k)s)
- Cardiac Recorders, Ltd. (8 510(k)s)
- Cardiac Pathways Corp. (5 510(k)s)
- Cardiac Assist Devices, Inc. (3 510(k)s)
- Cardiac Insight, Inc. (3 510(k)s)
- Cardiac Assist, Maquet Cardiovascular, LLC (2 510(k)s)
- Cardiac Designs, LLC (2 510(k)s)
- Cardiac Evaluation Center, Inc. (2 510(k)s)
- Cardiac Mariners, Inc. (2 510(k)s)
- Cardiac Telecom Corp. (2 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Cardiac Control Systems, Inc.?
FDA lists 26 510(k) clearances under the applicant name “Cardiac Control Systems, Inc.” (first 1983, latest 1997), plus 2 PMA decisions, across 6 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cardiac Control Systems, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cardiac Control Systems, Inc. is 70 days.
Which FDA product codes appear under Cardiac Control Systems, Inc.?
The most frequent FDA product codes under this applicant name are DXY (Implantable Pacemaker Pulse-Generator, 15); DTB (Permanent Pacemaker Electrode, 9); DTD (Pacemaker Lead Adaptor, 1).
Next steps
- See all 26 Cardiac Control Systems, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DXY, Cardiac Control Systems, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.