510(k) Report

510(k) · Cleared

Recalled · Class II · 2016

NRG Transseptal Needle

K073326510(k) TraditionalCleared May 28, 2008183-day reviewClass II21 CFR 870.5175Recalls 1

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 May 28, 2008 as substantially equivalent to K031949 (Baylis Medical Co., Inc., 2003) and 1 other predicate after a 183-day review. Its family tree reaches back 1 generation to 2002. 16 later devices descend from it. It has been recalled once.

Decided
May 28, 2008
Review
183 days
Class
Class II
Product code
DXF
Recalls
1
Predicates
2

Its longest line of descent runs back 1 generation to K011727 (2002). 2 ancestors in all. 16 later devices descend from it, 5 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2003: 1 other ancestor2023: 2 descendants cleared2020: 1 descendant cleared2015: 1 descendant cleared2021: 1 descendant cleared2024: 5 descendants cleared2026: 4 descendants cleared2025: 2 descendants clearedK011727 · Transseptal Needle/Trocar · Thomas Medical Products, Inc. · 2002 · recalled200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 5 descendants2 generations forward: 6 descendants3 generations forward: 4 descendants4 generations forward: 1 descendant K011727 · Transseptal Needle/Trocar · Thomas Medical Products, Inc. · 2002 · recalled0
  1. Root · 1 generation backK011727 Transseptal Needle/TrocarThomas Medical Products, Inc. · 2002 · Recalled
  2. This deviceK073326 NRG Transseptal NeedleBaylis Medical Co., Inc. · 2008
  3. Descendant · cites it directly · 7 of its ownK150709 ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · Recalled
  4. Descendant · cites it directly · 3 of its ownK232852 Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. · 2023
  5. Descendant · 2 generations on · 2 of its ownK242076 VersaCross™ RF WireBaylis Medical Company · 2024
  6. Descendant · 2 generations on · 2 of its ownK241414 CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A…Circa Scientific, Inc. · 2024
  7. Descendant · 2 generations on · 2 of its ownK240900 HOTWIRE™ RF GuidewireAtraverse Medical · 2024

Showing 5 of 16 descendants. See all descendants

Descendants cleared per year

2015: 12020: 12021: 12023: 22024: 52025: 22026: 4
2015high 5 (2024) · low 0 (2016)2026

Most influential descendants

Showing 5 of 16 · See all
  • K150709ProTrack RF Anchor WireBaylis Medical Company, Inc. · 2015 · cites it directly7descendants
  • K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc. · 2023 · cites it directly3descendants
  • K242076VersaCross™ RF WireBaylis Medical Company · 2024 · 2 generations on2descendants
  • K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)…Circa Scientific, Inc. · 2024 · 2 generations on2descendants
  • K240900HOTWIRE™ RF GuidewireAtraverse Medical · 2024 · 2 generations on2descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K011727Transseptal Needle/TrocarThomas Medical Products, Inc.20021
0 (this device)K073326NRG Transseptal NeedleBaylis Medical Co., Inc.2008—
+1K150709ProTrack RF Anchor WireBaylis Medical Company, Inc.20151
+1K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc.2023—
+2K242076VersaCross™ RF WireBaylis Medical Company2024—
+2K241414CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W…Circa Scientific, Inc.2024—
+2K240900HOTWIRE™ RF GuidewireAtraverse Medical2024—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200310

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
202010
202110
202320
202450
202520
202640
FIG. 1 — Lineage of K073326, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (2)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K031949Toronto RF Septostomy Catheter, Model TSC-50-75
Summary page 1
…of Predicate Device Predicate devices are the Toronto RF Septostomy Catheter (Baylis Medical Company, Inc.), which is cleared under 510(k) Premarket Notification Number K03 1949 and the Transseptal Needle/Trocar (Thomas Medical Products, Inc), which is cleared under the 5 10(k) Premarket Notification numbe…
Baylis Medical Co., Inc.2003—
*K011727Transseptal Needle/TrocarThomas Medical Products, Inc.20021

What descends from it? (16)

See all 16

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K150709ProTrack RF Anchor WireBaylis Medical Company, Inc.20157
K232852Cross Vascular RF Transseptal Needle, Cross Vascular Connection CableCross Vascular, Inc.20233
K203459SafeCross Transseptal Puncture and Introducer (TSP/I) SystemEast End Medical I, LLC20212
K200060Reprocessed NRG Transseptal NeedleInnovative Health, LLC20201
K213584Reprocessed NRG Transseptal NeedleInnovative Health, LLC20230

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

Recalls of this device

DateClassRecallRoot causeReason
Oct 11, 2016Class IIZ-0393-2017Packaging process controlThe firm is voluntarily recalling lots of the NRG Transseptal Needle and NRG RF Transseptal Kit due to the possibility for an integrity defect to the Tyvek pouch of the NRG Transseptal Needle.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 1 of the 2 ancestors has a recall of any class.
  • Of its descendants, K150709 (Baylis Medical Company, Inc., 2015) has gone furthest, with 7 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. 2008, this device’s year, is highlighted.

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 summary.

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/K073326 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073326: NRG Transseptal Needle.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073326

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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