# K970229: Arrow Transseptal Super Arrow-Flex Percutaneous Set

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Feb 13, 1998 after 388 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
27 later devices descend from it; 6 cite it directly.
0 of 28 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) Arrow Super Arrow-Flex® percutaneous sheath introducer sets: named in the summary without a submission number
- (no number) Bard Mullins transseptal catheter introducer set: named in the summary without a submission number
- (no number) Daig Fast-Cath™ transseptal introducer: named in the summary without a submission number

## Most influential descendants
- K081341: Reinforced Catheter Introducer System (Rcis) (2008), 13 descendants of its own
- K043084: Premere Delivery Sheath, Model PDS (2005), 9 descendants of its own
- K101497: Delivery Sheath, Model Adelante Breezeway (2010), 8 descendants of its own
- K083793: Steerable Guide Catheter (2009), 8 descendants of its own
- K120459: Steerable Guiding Sheath, Model Adelante Destino (2012), 7 descendants of its own

## Indications for use
The Arrow Transseptal Super Arrow-Flex® Percutaneous Sheath Introducer set, is intended for use in the hospital catheterization laboratory for the percutaneous introduction of various cardiovascular devices into the left side of the heart through the interatrial septum.

Source page: https://510kreport.com/device/K970229
Methodology: https://510kreport.com/methodology