# K961499: Laguna Softip Diagnostic Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Oct 17, 1996 after 182 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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) Softip® High Flow diagnostic catheter (5 FR, 7 FR): named in the summary without a submission number
- (no number) INFINITI™ diagnostic catheter (5 FR): named in the summary without a submission number
- (no number) SUPER TORQUEPLUS™ diagnostic catheter (7 FR): named in the summary without a submission number
- (no number) GUIDEZILLA™ Softip® guiding catheters (packaging & sterilization): named in the summary without a submission number

## Indications for use
The LAGUNA™ Softip® diagnostic catheter is designed for delivering radiopaque media to selected sites in the vascular system.

Source page: https://510kreport.com/device/K961499
Methodology: https://510kreport.com/methodology