# K990284: Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical Connector Cable

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Co., Inc.
- Decided: Feb 1, 2001 after 734 days
- Product code: DXF (Catheter, Septostomy)
- Device class: 2
- Regulation: 21 CFR 870.5175
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K150709: ProTrack RF Anchor Wire (2015), 7 descendants of its own
- K242076: VersaCross™ RF Wire (2024), 2 descendants of its own
- K240900: HOTWIRE™ RF Guidewire (2024), 2 descendants of its own
- K252419: Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX) (2025), 1 descendant of its own
- K261745: LightningWire Transseptal Puncture System (TPS) (2026), 0 descendants of its own

## Indications for use
To create an atrial septal defect in the heart. Transseptal left heart access.

Source page: https://510kreport.com/device/K990284
Methodology: https://510kreport.com/methodology