Cathlab Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Cathlab Corp.” (first 1988, latest 1991), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 98 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 |
|---|---|---|---|
| DXE | Catheter, Embolectomy | 4 | 4 |
| DQO | Catheter, Intravascular, Diagnostic | 1 | 1 |
| DQT | Occluder, Catheter Tip | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| GCA | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection | 1 | 1 |
Review panels
Most recent Cathlab Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K910917 | CATHLAB SILICONE BILIARY BALLOON CATHETER | GCA | 1991-08-02 | 150 |
| K910916 | CATHLAB SILICONE OCCLUSION BALLOON CATHETER | DQT | 1991-06-24 | 111 |
| K905139 | CATHLAB SILICONE ARTERIAL EMBOLECTOMY CATHETER | DXE | 1991-02-25 | 108 |
| K897051 | MILLER PERCUTANEOUS ANGIOGRAPHIC/SCOPIC IRRI. CATH | DQO | 1990-03-16 | 88 |
| K897184 | 3F AND 4F IRRIGATION EMBOLECTOMY CATHETERS | DXE | 1990-03-14 | 76 |
| K893435 | SILICONE FLOW-DIRECTED THERMODILUTION CATHETER | DYG | 1989-09-26 | 147 |
| K893680 | SILICONE BI-LUMEN IRRIGATION EMBOLECTOMY CATH. | DXE | 1989-08-01 | 77 |
| K881455 | EMBOLECTOMY CATHETER(MODIFIED) | DXE | 1988-06-15 | 70 |
Recalls
openFDA lists no recalls under a recalling firm named Cathlab 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 Cathlab Corp.?
FDA lists 8 510(k) clearances under the applicant name “Cathlab Corp.” (first 1988, latest 1991), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Cathlab Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cathlab Corp. is 98 days.
Which FDA product codes appear under Cathlab Corp.?
The most frequent FDA product codes under this applicant name are DXE (Catheter, Embolectomy, 4); DQO (Catheter, Intravascular, Diagnostic, 1); DQT (Occluder, Catheter Tip, 1).
Next steps
- See all 8 Cathlab Corp. clearances with predicates and recalls
- Run predicate analysis for product code DXE, Cathlab 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.