510(k) Report

510(k) · Cleared

Cleared

Toronto RF Septostomy Catheter, Model TSC-50-75

K031949510(k) TraditionalCleared Dec 10, 2003169-day reviewClass II21 CFR 870.5175

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Baylis Medical Co., Inc. · DXF Catheter, Septostomy

Cleared on Dec 10, 2003 after a 169-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 17 later devices descend from it.

Decided
Dec 10, 2003
Review
169 days
Class
Class II
Product code
DXF
Recalls
None
Predicates
0

17 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2008: 1 descendant cleared2023: 2 descendants cleared2020: 1 descendant cleared2015: 1 descendant cleared2021: 1 descendant cleared2024: 5 descendants cleared2026: 4 descendants cleared2025: 2 descendants cleared200020052010201520202025
  1. This deviceK031949 Toronto RF Septostomy Catheter, Model TSC-50-75Baylis Medical Co., Inc. · 2003
  2. Descendant · cites it directly · 16 of its ownK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · Recalled
  3. Descendant · 2 generations on · 7 of its ownK150709 ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · Recalled
  4. Descendant · 2 generations on · 3 of its ownK232852 Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. · 2023
  5. Descendant · 3 generations on · 2 of its ownK242076 VersaCross™ RF WireBaylis Medical Company · 2024
  6. Descendant · 3 generations on · 2 of its ownK241414 CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A…Circa Scientific, Inc. · 2024

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

2008: 12015: 12020: 12021: 12023: 22024: 52025: 22026: 4
2008high 5 (2024) · low 0 (2009)2026

Most influential descendants

Showing 5 of 17 · See all
  • K073326NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008 · cites it directly16descendants
  • K150709ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · 2 generations on7descendants
  • K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. · 2023 · 2 generations on3descendants
  • K242076VersaCross™ RF WireBaylis Medical Company · 2024 · 3 generations on2descendants
  • K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…Circa Scientific, Inc. · 2024 · 3 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K031949Toronto RF Septostomy Catheter, Model TSC-50-75Baylis Medical Co., Inc.2003—
+1K073326NRG Transseptal NeedleBaylis Medical Co., Inc.20081
+2K150709ProTrack RF Anchor WireBaylis Medical Company, Inc.20151
+2K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc.2023—
+3K242076VersaCross™ RF WireBaylis Medical Company2024—
+3K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W…Circa Scientific, Inc.2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200810
201510
202010
202110
202320
202450
202520
202640
FIG. 1 — Lineage of K031949, 2003–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DXF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DXF device

  1. #1 K242076 VersaCross™ RF Wirescore 14.9 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (17)

See all 17

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K073326NRG Transseptal NeedleBaylis Medical Co., Inc.200816

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K073326 (Baylis Medical Co., Inc., 2008) has gone furthest, with 16 descendants of its own.

How does its category compare?

All DXF devices

DXF Catheter, Septostomy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DXF

2in 2025

2008: 12015: 12019: 12021: 12022: 12023: 12024: 42025: 22026 (partial year): 3
2007high 4 (2024) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DXF

83in 2024

2024: 83 days median2026 (partial year): 30 days median
2007high 83 (2024)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DXF

3in 2020

2016: 12020: 3, 3 Class I
2007high 3 (2020) · low 0 (2007)2026

Class I (3 since 2007) Class II/III not classified

Adverse event reports per year · DXF

682in 2025

2007: 22008: 82009: 32010: 42011: 62012: 22013: 12014: 42015: 212016: 132017: 132018: 362019: 242020: 552021: 392022: 702023: 2862024: 3682025: 682
2007high 682 (2025) · low 1 (2013)2025

MAUDE reports naming product code DXF, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—02
20081—08
20090—03
20100—04
20110—06
20120—02
20130—01
20140—04
20151—021
20160—113
20170—013
20180—036
20191—024
20200—3 (3)55
20211—039
20221—070
20231—0286
20244830368
20252—0682
20263300—

What is it indicated for?

Creation of an atrial septal defect in the heart. Secondary applications include transseptal heart access, monitoring intracardiac pressures, sampling blood, and infusing solutions.

Indications for use as stated in the FDA 510(k) statement.

More from Baylis Medical Co., Inc.

28 FDA decisions under this applicant name. See the company

  • K122926Sureflex Steerable Guiding Sheath KitBaylis Medical Co., Inc. · 2013
  • K111523Osteocool (TM) RF Ablation SystemBaylis Medical Co., Inc. · 2012
  • K102948Torflex Transseptal Guiding SheathBaylis Medical Co., Inc. · 20111 Class I recall
  • K102192Indiscal Digital ManometerBaylis Medical Co., Inc. · 2011
  • K101372Duocool Pain Management Probe, Model Osp-17-180-20Baylis Medical Co., Inc. · 2010

Recent decisions in DXF

The DXF category page

  • K261745LightningWire Transseptal Puncture System (TPS)ElectroWire Medical · 2026
  • K253799SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)Pressure Products Medical Device Manufacturing, LLC · 2026
  • K260292Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical · 2026
  • K252419Hotwire RF Guidewire (901XXX); Hotwire RF Guidewire (902XXX)Atraverse Medical, Inc. · 2025
  • K251007CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V…Circa Scientific, Inc. · 2025

https://510kreport.com/device/K031949 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031949: Toronto RF Septostomy Catheter, Model TSC-50-75.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031949

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026