# K984214: Cordis Endovascular Temporary Occlusion Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Cordis Neurovascular, Inc.
- Decided: Aug 10, 1999 after 259 days
- Product code: DXC (Clamp, Vascular)
- Device class: 2
- Regulation: 21 CFR 870.4450
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
0 of 32 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) Prowler Infusion Catheter: named in the summary without a submission number
- (no number) NDSB Balloon Catheter: named in the summary without a submission number
- (no number) NDSB Occlusion Balloon Catheter: named in the summary without a submission number
- (no number) NDSB Balloon Catheter: named in the summary without a submission number

## Most influential descendants
- K041151: Kerberos Occluding Guide Catheter and Accessories (2004), 25 descendants of its own
- K080987: Bridgepoint Medical Stingray Device and Accessories (2009), 24 descendants of its own
- K101591: Stingray Orienting Balloon Catheter (2010), 14 descendants of its own
- K102725: Crossboss Catheter Model M-2000, Stingray Orienting Balloon Catheter Model M-1000, Stingray Guidewire Model M-3004 and M (2011), 11 descendants of its own
- K121763: Multicross Support Catheter (2012), 8 descendants of its own

## Indications for use
The Temporary Occlusion Balloon Catheter is intended for the temporary occlusion of blood vessels in neuro and peripheral vasculature.

Source page: https://510kreport.com/device/K984214
Methodology: https://510kreport.com/methodology