DXF · Class II · 21 CFR 870.5175

FDA Product Code DXF: Catheter, Septostomy

Leading manufacturers include Circa Scientific, Inc., NuMED, Inc. and Baylis Medical Co., Inc..

21
Total
21
Cleared
108d
Avg days
1980
Since
Growing category - 6 submissions in the last 2 years vs 4 in the prior period
Review times improving: avg 46d recently vs 133d historically

FDA 510(k) Cleared Catheter, Septostomy Devices (Product Code DXF)

21 devices
1–21 of 21
Cleared Jun 26, 2026
LightningWire Transseptal Puncture System (TPS)
K261745
ElectroWire Medical
Cardiovascular · 30d
Cleared Mar 13, 2026
SafeSept RF Transseptal Guidewire (SSRF132
K253799
Pressure Products Medical Device Manufacturing, LLC
Cardiovascular · 105d
Cleared Feb 27, 2026
HOTWIRE RF GUIDEWIRE (901XXX)
K260292
Atraverse Medical
Cardiovascular · 29d
Cleared Aug 27, 2025
HOTWIRE RF GUIDEWIRE (901XXX)
K252419
Atraverse Medical, Inc.
Cardiovascular · 26d
Cleared May 01, 2025
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
K251007
Circa Scientific, Inc.
Cardiovascular · 30d
Cleared Nov 26, 2024
Cross Wise™ Multi-Use RF Adapter Cable
K243193
Circa Scientific, Inc.
Cardiovascular · 57d
Cleared Nov 01, 2024
VersaCross™ RF Wire
K242076
Baylis Medical Company
Cardiovascular · 108d
Cleared Sep 26, 2024
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C)
K241414
Circa Scientific, Inc.
Cardiovascular · 132d
Cleared May 01, 2024
HOTWIRE™ RF Guidewire
K240900
Atraverse Medical
Cardiovascular · 30d
Cleared Oct 12, 2023
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
K232852
Cross Vascular, Inc.
Cardiovascular · 28d
Cleared Aug 22, 2022
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
K221528
Edwards Lifesciences, LLC
Cardiovascular · 88d
Cleared Jul 19, 2021
Z-6 Atrioseptostomy Catheter
K211910
NuMED, Inc.
Cardiovascular · 28d
Cleared Apr 04, 2019
Park Blade Septostomy Catheter
K182399
Cook Incorporated
Cardiovascular · 212d
Cleared Jun 17, 2015
ProTrack RF Anchor Wire
K150709
Baylis Medical Company, Inc.
Cardiovascular · 90d
Cleared May 28, 2008
NRG TRANSSEPTAL NEEDLE
K073326
Baylis Medical Co., Inc.
Cardiovascular · 183d
Cleared Dec 10, 2003
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
K031949
Baylis Medical Co., Inc.
Cardiovascular · 169d
Cleared Jul 12, 2001
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
K011557
NuMED, Inc.
Cardiovascular · 52d
Cleared Feb 01, 2001
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
K990284
Baylis Medical Co., Inc.
Cardiovascular · 734d
Cleared Jul 12, 2000
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
K001804
NuMED, Inc.
Cardiovascular · 27d
Cleared Mar 31, 1986
REGULATED PRESSURE INJECTOR
K860806
Target Therapeutics
Cardiovascular · 27d
Cleared Jul 28, 1980
BLADE SEPTOSTOMY CATHETER
K801031
Cook, Inc.
Cardiovascular · 88d

About Product Code DXF - Regulatory Context

510(k) Submission Activity

21 total 510(k) submissions under product code DXF since 1980, with 21 receiving FDA clearance (average review time: 108 days).

Submission volume has increased in recent years - 6 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - DXF Product Code

Recent submissions under DXF have taken an average of 46 days to reach a decision - down from 133 days historically, suggesting improved FDA processing for this classification.

DXF devices are reviewed by the Cardiovascular panel. Browse all Cardiovascular devices →