Daig Corp.: FDA filings under this applicant name
FDA lists 63 510(k) clearances under the applicant name “Daig Corp.” (first 1977, latest 2000), across 10 product codes in 1 review panel. Median 510(k) review time under this name: 89 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 |
|---|---|---|---|
| DTB | Permanent Pacemaker Electrode | 28 | 28 |
| DYB | Introducer, Catheter | 18 | 18 |
| DQO | Catheter, Intravascular, Diagnostic | 4 | 4 |
| DRF | Catheter, Electrode Recording, Or Probe, Electrode Recording | 3 | 3 |
| DTD | Pacemaker Lead Adaptor | 3 | 3 |
| LDF | Electrode, Pacemaker, Temporary | 3 | 3 |
| DQR | Cannula, Catheter | 1 | 1 |
| DRA | Catheter, Steerable | 1 | 1 |
| DRE | Dilator, Vessel, For Percutaneous Catheterization | 1 | 1 |
| DSA | Cable, Transducer And Electrode, Patient, (Including Connector) | 1 | 1 |
Review panels
- Cardiovascular (63)
Most recent Daig Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K000004 | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 | DYB | 2000-11-29 | 331 |
| K994334 | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX | DYB | 2000-05-15 | 144 |
| K982299 | SPYGLASS 5 FR ANGIOGRAPHIC CATHETER | DQO | 1998-10-19 | 110 |
| K982187 | FAST-CATH INTRA-CARDIAC INTRODUCER | DYB | 1998-09-16 | 86 |
| K973840 | FAST-CATH (TM) INTRA-CARDIAC INTRODUCER | DYB | 1998-05-21 | 225 |
| K964518 | FAST-CATH TRANSSEPTAL CATHETER INTRODUCER | DYB | 1997-05-14 | 201 |
| K965249 | SPYGLASS ANGIOGRAPHIC CATHETER | DQO | 1997-02-21 | 71 |
| K962805 | SPYGLASS ANGIOGRAPHIC CATHETER | DQO | 1996-10-15 | 89 |
| K954317 | DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS | DYB | 1995-11-28 | 74 |
| K944284 | CONTROL | DQO | 1995-03-03 | 182 |
53 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Daig Corp..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Daig Corp.?
FDA lists 63 510(k) clearances under the applicant name “Daig Corp.” (first 1977, latest 2000), across 10 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 Daig Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Daig Corp. is 89 days.
Which FDA product codes appear under Daig Corp.?
The most frequent FDA product codes under this applicant name are DTB (Permanent Pacemaker Electrode, 28); DYB (Introducer, Catheter, 18); DQO (Catheter, Intravascular, Diagnostic, 4).
Next steps
- See all 63 Daig Corp. clearances with predicates and recalls
- Run predicate analysis for product code DTB, Daig Corp.'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.