Electro-Catheter Corp.: FDA clearances and approvals
Electro-Catheter Corp. has 35 FDA 510(k) clearances (first 1976, latest 1995), across 17 product codes in 6 review panels. Median 510(k) review time: 38 days.
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 |
|---|---|---|---|
| LDF | Electrode, Pacemaker, Temporary | 7 | 7 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 5 | 5 |
| DXG | Computer, Diagnostic, Pre-Programmed, Single-Function | 4 | 4 |
| DTR | Heat-Exchanger, Cardiopulmonary Bypass | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| DQX | Wire, Guide, Catheter | 2 | 2 |
| DYG | Catheter, Flow Directed | 2 | 2 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 | 1 |
| DQR | Cannula, Catheter | 1 | 1 |
| DTB | Permanent Pacemaker Electrode | 1 | 1 |
Plus 7 more product codes.
Review panels
- Cardiovascular (30)
- Anesthesiology (1)
- Gastroenterology and Urology (1)
- Ophthalmic (1)
- Physical Medicine (1)
- General and Plastic Surgery (1)
Most recent Electro-Catheter Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K934785 | MULTIPACE | LDF | 1995-07-27 | 660 |
| K943257 | TIP DEFLECTOR (GENESIS) | DRF | 1995-04-19 | 287 |
| K933451 | OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION | DRF | 1995-04-19 | 646 |
| K933450 | CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION | DRF | 1995-04-19 | 646 |
| K934787 | SILICORE SEMI-FLOATER | LDF | 1995-02-24 | 507 |
| K874154 | ELECATH(R) TRANSESOPHAGEAL PACING CATHETER | KNT | 1988-04-29 | 199 |
| K854511 | ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET | DQX | 1986-02-10 | 90 |
| K854975 | ELECATH PULSATILE PERFUSION PUMP | KFM | 1986-01-15 | 34 |
| K850065 | ELECATH TORKFLOAT PACING PROBE | DTB | 1985-04-10 | 92 |
| K850324 | ELECATH OPEN TIP BIPOLAR PACING CATHETER | LDF | 1985-03-27 | 58 |
25 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Electro-Catheter Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Electro-Catheter Corp. have?
Electro-Catheter Corp. has 35 FDA 510(k) clearances (first 1976, latest 1995), across 17 product codes in 6 review panels.
How long does FDA take to clear Electro-Catheter Corp.'s 510(k)s?
The median time from FDA receipt to decision across Electro-Catheter Corp.'s cleared 510(k)s is 38 days.
What devices does Electro-Catheter Corp. make?
Its most frequent FDA product codes are LDF (Electrode, Pacemaker, Temporary, 7); DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording, 5); DXG (Computer, Diagnostic, Pre-Programmed, Single-Function, 4).
Has Electro-Catheter Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Electro-Catheter Corp. Related entities may recall under other names.
Next steps
- See all 35 Electro-Catheter Corp. clearances with predicates and recalls
- Run predicate analysis for product code LDF, Electro-Catheter Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.