Vas-Cath of Canada , Ltd.: FDA clearances and approvals
Vas-Cath of Canada , Ltd. has 19 FDA 510(k) clearances (first 1979, latest 1988), across 9 product codes in 4 review panels. Median 510(k) review time: 76 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 |
|---|---|---|---|
| LFJ | Catheter, Subclavian | 8 | 8 |
| FIQ | Cannula, A-V Shunt | 3 | 3 |
| DQO | Catheter, Intravascular, Diagnostic | 2 | 2 |
| BSO | Catheter, Conduction, Anesthetic | 1 | 1 |
| CAZ | Anesthesia Conduction Kit | 1 | 1 |
| DQY | Catheter, Percutaneous | 1 | 1 |
| FJS | Catheter, Peritoneal, Long-Term Indwelling | 1 | 1 |
| JCY | Catheter, Infusion | 1 | 1 |
| KNZ | Accessories, A-V Shunt | 1 | 1 |
Review panels
- Gastroenterology and Urology (13)
- Cardiovascular (3)
- Anesthesiology (2)
- General and Plastic Surgery (1)
Most recent Vas-Cath of Canada , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K875188 | LUER LOCK CONNECTORS / RIDIG P.V.C. | LFJ | 1988-03-02 | 76 |
| K871817 | VAS-CATH PERITONEAL DIALYSIS CATHETER | FJS | 1987-07-16 | 66 |
| K871488 | VAS-CATH PERMANENT DUAL LUMEN HEMODIALYSIS CATH | LFJ | 1987-06-12 | 58 |
| K871487 | VAS-CATH PERMANENT SINGLE LUMEN HEMODIALYSIS CATH | LFJ | 1987-06-12 | 58 |
| K863982 | VAS-CATH PERICARDIOCENTESIS CATHETER, SET & TRAY | JCY | 1986-10-24 | 10 |
| K853283 | VACCESS TM 4006 | LFJ | 1985-08-22 | 17 |
| K844854 | OPTI-FLOW DIGITAL SUBTRACTION ANGIOGRAPHY CAT-KIT | DQO | 1985-05-21 | 159 |
| K844800 | OPTI-FLOW & OPTI-TORQUE ANGIOGRAPHIC CATHETERS | DQO | 1985-05-16 | 156 |
| K850009 | EVANS, VAS-CATH EPIDURAL NEEDLE & CATHETER | BSO | 1985-05-13 | 131 |
| K844434 | VACCESS 3000 SINGLE LUMEN JUGULAR CANNULA-CATH | LFJ | 1985-03-13 | 117 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Vas-Cath of Canada , Ltd..
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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of Vas-Cath of Canada , Ltd.'s product codes (a text match, not an official crosswalk):
- E0786 — Implantable programmable infusion pump, replacement (excludes implantable intraspinal catheter) (via JCY)
- E0785 — Implantable intraspinal (epidural/intrathecal) catheter used with implantable infusion pump, replacement (via JCY)
Frequently asked questions
How many FDA 510(k) clearances does Vas-Cath of Canada , Ltd. have?
Vas-Cath of Canada , Ltd. has 19 FDA 510(k) clearances (first 1979, latest 1988), across 9 product codes in 4 review panels.
How long does FDA take to clear Vas-Cath of Canada , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Vas-Cath of Canada , Ltd.'s cleared 510(k)s is 76 days.
What devices does Vas-Cath of Canada , Ltd. make?
Its most frequent FDA product codes are LFJ (Catheter, Subclavian, 8); FIQ (Cannula, A-V Shunt, 3); DQO (Catheter, Intravascular, Diagnostic, 2).
Has Vas-Cath of Canada , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Vas-Cath of Canada , Ltd. Related entities may recall under other names.
Next steps
- See all 19 Vas-Cath of Canada , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LFJ, Vas-Cath of Canada , Ltd.'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.