# K021593: Modification to Envoy and Vista Brite Tip

- Pathway: 510(k) (Special)
- Applicant: Cordis Corp.
- Decided: Jun 13, 2002 after 29 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 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 Vista Brite Tip Guiding Catheters: named in the summary without a submission number
- (no number) Cordis Envoy Guiding Catheters: named in the summary without a submission number

## Most influential descendants
- K082143: Micro Guide Catheter XP (2008), 2 descendants of its own
- K140438: Micro Guide Catheter Elite (2014), 1 descendant of its own
- K150187: ELITECROSS Support Catheter (2015), 0 descendants of its own

## Recalls of this device
- Feb 7, 2025 · Class II · Z-1330-2025: Catheter manufactured at the incorrect length.
- Feb 7, 2019 · Class III · Z-1198-2019: Frayed pieces of the mounting card being inside the primary packaging.
- Dec 7, 2004 · Not classified · Z-0434-05: Two complaints have been received and confirmed, regarding a lot, indicating that the distal end had an 'RDC' shape rather than the 'RDC(1)' shape. The RDC shape has a larger curve. The product was ma

## Indications for use
Vista Brite Tip - The guiding catheter is intended for use for intravascular introduction of interventional / diagnostic devices into the coronary or 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/K021593
Methodology: https://510kreport.com/methodology