Diag Corp.: FDA clearances and approvals
Diag Corp. has 9 FDA 510(k) clearances (first 1980, latest 1999), across 4 product codes in 1 review panel. Median 510(k) review time: 99 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 5 | 5 |
| DYB | Introducer, Catheter | 2 | 2 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
| LDF | Electrode, Pacemaker, Temporary | 1 | 1 |
Review panels
- Cardiovascular (9)
Most recent Diag Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K984062 | SEAL-AWAY HEMOSTASIS ADAPTER, MODEL 406229 | DYB | 1999-03-24 | 128 |
| K911883 | DAIG FAST CATH(TM) TRANSSEPTAL SHEATH INTRODUCER | DYB | 1991-11-29 | 214 |
| K910645 | DISPOSABLE PATIENT CABLE | DSA | 1991-05-07 | 83 |
| K852446 | ENDOCARDIAL SCREW-IN LEAD WITH PLATINUM POROUS TIP | DTB | 1985-09-17 | 99 |
| K820003 | CARDIOVASCULAR TEMP. PACEMAKER ELEC | LDF | 1982-03-26 | 81 |
| K820262 | PERMANENT & TEMPORARY PACEMAKER ELECTR. | DTB | 1982-03-12 | 38 |
| K812905 | PERMANENT ENDOCARD. UNIPOLAR TINED LEAD | DTB | 1982-02-04 | 108 |
| K812270 | PERM. ENDOCARDIAL UNIPOLAR TINED ATRIAL | DTB | 1981-09-16 | 34 |
| K800349 | ENDOCARD. PACING LEAD LONG LENGTH PL200 | DTB | 1980-05-28 | 103 |
Recalls
openFDA lists no recalls under a recalling firm named Diag 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 Diag Corp. have?
Diag Corp. has 9 FDA 510(k) clearances (first 1980, latest 1999), across 4 product codes in 1 review panel.
How long does FDA take to clear Diag Corp.'s 510(k)s?
The median time from FDA receipt to decision across Diag Corp.'s cleared 510(k)s is 99 days.
What devices does Diag Corp. make?
Its most frequent FDA product codes are DTB (Permanent Pacemaker Electrode, 5); DYB (Introducer, Catheter, 2); DSA (Cable, Transducer And Electrode, Patient, (Including Connector), 1).
Has Diag Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Diag Corp. Related entities may recall under other names.
Next steps
- See all 9 Diag Corp. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Diag 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.