# K150709: ProTrack RF Anchor Wire

- Pathway: 510(k) (Traditional)
- Applicant: Baylis Medical Company, Inc.
- Decided: Jun 17, 2015 after 90 days
- Product code: DXF (Catheter, Septostomy)
- Device class: 2
- Regulation: 21 CFR 870.5175
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K011727 (2002). 4 ancestors in all.
7 later devices descend from it; 3 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K990284: Baylis Medical RF Septostomy Generator, Nykanen RF Septostomy Catheter, Baylis Medical Connector Cable, Baylis Medical Co., Inc. (2001) Summary page 4.
- K073326: NRG Transseptal Needle, Baylis Medical Co., Inc. (2008) Summary page 4.

## Most influential descendants
- 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
- K260839: Protaryx Transseptal  Puncture Device (PTX2-001) (2026), 0 descendants of its own

## Recalls of this device
- Jun 10, 2025 · Class II · Z-2103-2025: Potential for hole in the Tyvek layer of the sterile barrier pouch, which may compromise device sterility. Issue could potentially lead to systemic infection and sepsis in worst case scenario. Potenti

## Indications for use
The ProTrack RF Anchor Wire is indicated for the creation of an atrial septal defect in the heart.

Source page: https://510kreport.com/device/K150709
Methodology: https://510kreport.com/methodology