# K961999: Schneider Guider Softip Guiding Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Scimed, Inc.
- Decided: Nov 19, 1996 after 181 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
28 later devices descend from it; 2 cite it directly.
0 of 29 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) Petite brite tip® guiding catheter (6 FR): named in the summary without a submission number
- (no number) Vista brite tip™ guiding catheter (10 FR): named in the summary without a submission number
- (no number) TRIGUIDE® guiding catheter (10 FR): named in the summary without a submission number
- (no number) DVI guiding catheter (10 FR): named in the summary without a submission number
- (no number) SOLID-7 guiding catheter (packaging only): named in the summary without a submission number

## Most influential descendants
- K980453: Schneider Guider Softip Guiding Catheters (1998), 26 descendants of its own
- K071226: 8FR Turbo Booster, Guide Catheter, 7FR Turbo Booster, Model 518-063, 518-043 (2007), 21 descendants of its own
- K091299: Spectranetics Turbo-Tandem System (2009), 20 descendants of its own
- K094036: Turbo-Tandem System Model 472-110 (2010), 19 descendants of its own
- K140775: Turbo-Elite Atherectomy Catheters, Turbo Tandem System (2014), 17 descendants of its own

## Indications for use
The SCHNEIDER GUIDER Softip® guiding catheter is designed for the intravascular introduction of interventional devices.

Source page: https://510kreport.com/device/K961999
Methodology: https://510kreport.com/methodology