510(k) K021593 ยท DQY Catheter, Percutaneous
MODIFICATION TO ENVOY AND VISTA BRITE TIP
| Applicant | Cordis Corp., Miami Lakes FL, US |
| Decision | Substantially Equivalent, Jun 13, 2002 |
| Received | May 15, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K021593
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2025 | Cordis US Corp Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F.
Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or Open, Classified |
DQY | None listed |
| Feb 7, 2019 | Cordis Corporation Cordis Vista Brite Tip & Androit Guiding Catheters
Product Usage:
The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or per Terminated |
DQY | None listed |
| Jan 26, 2005 | Cordis Corporation VISTA BRITE TIP RDC(1) Guiding Catheter. Product Code 67021055, lot X0704002, Precutaneous Catheter. Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.