# K962362: Cordis Envoy & Vista Brite Tip Guiding Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Corp.
- Decided: Aug 8, 1996 after 50 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Cordis ENVOY: named in the summary without a submission number
- (no number) Cordis Vista Brite Tip: named in the summary without a submission number

## Most influential descendants
- K141981: Asahi Fubuki 043 / Asahi Fubuki (2015), 2 descendants of its own
- K213589: FUBUKI XF Neurovascular Long Sheath (2022), 1 descendant of its own
- K971646: 4F Nylex Angiography Catheter/5F Nylex Angiography Catheter (1997), 1 descendant of its own
- K251560: FUBUKI XF-R Neurovascular Long Sheath (2025), 0 descendants of its own
- K181836: 4F Infiniti Angiographic Catheter, 4F & 5F Nylex Angiography Catheters, 4F & 5F Tempo Angiography Catheters (2018), 0 descendants of its own

## Indications for use
Vista Brite Tip: The guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary and peripheral vascular systems. ENVOY: The ENVOY Guiding Catheter is intended for use in the peripheral, coronary and neurovasculature for the intravascular introduction of interventional/diagnostic devices.

Source page: https://510kreport.com/device/K962362
Methodology: https://510kreport.com/methodology