DXF · Class II · 21 CFR 870.5175

FDA Product Code DXF: Catheter, Septostomy

Leading manufacturers include Circa Scientific, Inc., Atraverse Medical and Pressure Products Medical Device Manufacturing, LLC.

20
Total
20
Cleared
112d
Avg days
1980
Since
Growing category - 7 submissions in the last 2 years vs 3 in the prior period
Review times improving: avg 70d recently vs 135d historically

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

20 devices
1–20 of 20
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

About Product Code DXF - Regulatory Context

510(k) Submission Activity

20 total 510(k) submissions under product code DXF since 1980, with 20 receiving FDA clearance (average review time: 112 days).

Submission volume has increased in recent years - 7 submissions in the last 24 months compared to 3 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 70 days to reach a decision - down from 135 days historically, suggesting improved FDA processing for this classification.

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