# K963988: Intravascular Infusion Device

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Dec 12, 1996 after 69 days
- Product code: KRA (Catheter, Continuous Flush)
- Device class: 2
- Regulation: 21 CFR 870.1210
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 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) Balt Magic Infusion Catheter: named in the summary without a submission number
- (no number) Transend Steerable Guidewire: named in the summary without a submission number

## Most influential descendants
- K984258: Neurovasx Sub-Microinfusion Catheter (1999), 1 descendant of its own
- K011646: Neuroedge Infusion  Catheter (2001), 0 descendants of its own

## Indications for use
The Intravascular Infusion Device is indicated for the infusion of diagnostic agents into the general vasculature including the peripheral, coronary and neurovasculature.

Source page: https://510kreport.com/device/K963988
Methodology: https://510kreport.com/methodology