Product Code: DXF FDA class 2 21 CFR 870.5175

Catheter, Septostomy

Cardiovascular

The Septostomy Catheter is a cardiovascular interventional device used to create or enlarge an opening in the interatrial septum of the heart, typically in neonates with certain congenital heart defects, to improve oxygenation by allowing mixing of oxygenated and deoxygenated blood. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DXF and it is regulated under 21 CFR 870.5175 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: DXF
Device Class: FDA class 2
Regulation Number: 870.5175
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 20 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K253799	SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)	Mar 13, 2026	Substantially Equivalent	Pressure Products Medical Device Manufacturing, LLC
K260292	HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)	Feb 27, 2026	Substantially Equivalent	Atraverse Medical
K252419	HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)	Aug 27, 2025	Substantially Equivalent	Atraverse Medical, Inc.
K251007	CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)	May 01, 2025	Substantially Equivalent	Circa Scientific, Inc.
K243193	Cross Wise Multi-Use RF Adapter Cable	Nov 26, 2024	Substantially Equivalent	Circa Scientific, Inc.
K242076	VersaCross RF Wire	Nov 01, 2024	Substantially Equivalent	Baylis Medical Company
K241414	CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)	Sep 26, 2024	Substantially Equivalent	Circa Scientific, Inc.
K240900	HOTWIRE RF Guidewire	May 01, 2024	Substantially Equivalent	Atraverse Medical
K232852	Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable	Oct 12, 2023	Substantially Equivalent	Cross Vascular, Inc.
K221528	Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter	Aug 22, 2022	Substantially Equivalent	Edwards Lifesciences, LLC
K211910	Z-6 Atrioseptostomy Catheter	Jul 19, 2021	Substantially Equivalent	NuMED, Inc.
K182399	Park Blade Septostomy Catheter	Apr 04, 2019	Substantially Equivalent	Cook Incorporated
K150709	ProTrack RF Anchor Wire	Jun 17, 2015	Substantially Equivalent	Baylis Medical Company, Inc.
K073326	NRG TRANSSEPTAL NEEDLE	May 28, 2008	Substantially Equivalent	Baylis Medical Co., Inc.
K031949	TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75	Dec 10, 2003	Substantially Equivalent	Baylis Medical Co., Inc.
K011557	PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS	Jul 12, 2001	Substantially Equivalent	NuMED, Inc.
K990284	BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE	Feb 01, 2001	Substantially Equivalent	Baylis Medical Co., Inc.
K001804	NUMED Z-5 ATRIOSEPTOSTOMY CATHETER	Jul 12, 2000	Substantially Equivalent	NuMED, Inc.
K860806	REGULATED PRESSURE INJECTOR	Mar 31, 1986	Substantially Equivalent	Target Therapeutics
K801031	BLADE SEPTOSTOMY CATHETER	Jul 28, 1980	Substantially Equivalent	Cook, Inc.