Catco Medical, Inc.: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Catco Medical, Inc.” (first 1994, latest 1995), across 7 product codes in 3 review panels. Median 510(k) review time under this name: 186 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | 5 | 5 |
| LJS | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | 2 | 2 |
| BRW | Protector, Dental | 1 | 1 |
| EZD | Catheter, Straight | 1 | 1 |
| FCN | Urinary Drainage Collection Kit, For Indwelling Catheter | 1 | 1 |
| JOL | Catheter And Tip, Suction | 1 | 1 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 1 | 1 |
Review panels
Most recent Catco Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K945728 | CATCO THORACIC CATHETER | JOL | 1995-05-23 | 182 |
| K944410 | CATCO SILICONE DUAL LUMEN UMBILICAL VESSEL CATHETER | FOZ | 1995-04-05 | 209 |
| K944368 | CATCO SILICONE UMBILICAL VESSEL CATHETER | FOZ | 1995-04-05 | 210 |
| K944367 | CATCO POLYURETHANE UMBILICAL VESSEL CATHETER | FOZ | 1995-04-05 | 210 |
| K944336 | CATCO UMBILICAL VESSEL CATHETER | FOZ | 1995-04-05 | 211 |
| K944685 | CATO FIRST PICC-DUAL LUMEN | LJS | 1995-03-31 | 190 |
| K944504 | CATCO FIRST PICC | FOZ | 1995-03-31 | 198 |
| K945012 | CATCO NUTRITIONAL CATHETER | KNT | 1995-02-24 | 134 |
| K945258 | CATCO URINARY COLLECTION KIT | FCN | 1995-02-16 | 111 |
| K945499 | CATO FIRST PICC KIT | LJS | 1995-02-07 | 90 |
2 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Catco Medical, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Catco Medical, Inc.?
FDA lists 12 510(k) clearances under the applicant name “Catco Medical, Inc.” (first 1994, latest 1995), across 7 product codes in 3 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 Catco Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Catco Medical, Inc. is 186 days.
Which FDA product codes appear under Catco Medical, Inc.?
The most frequent FDA product codes under this applicant name are FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, 5); LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days, 2); BRW (Protector, Dental, 1).
Next steps
- See all 12 Catco Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FOZ, Catco Medical, 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, 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.