Panels › Cardiovascular › Product code DXF · Class 2
Catheter, Septostomy
Regulation 870.5175
3510(k)s in 12 months (21 all time)
0recalls in 12 months (10 all time)
4recalls that name a 510(k)
Top companies in DXF
| Company | 510(k)s | Recalls |
|---|---|---|
| Baylis Medical Co., Inc. | 5 | 1 |
| Boston Scientific Corporation | 0 | 4 |
| Atraverse Medical | 3 | 0 |
| Circa Scientific, Inc. | 3 | 0 |
| Edwards Lifesciences, LLC | 1 | 2 |
| Medtronic Vascular | 0 | 3 |
| NuMED, Inc. | 3 | 0 |
| Cook Incorporated | 2 | 0 |
| Cross Vascular, Inc. | 1 | 0 |
| ElectroWire Medical | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 10, 2025 | Boston Scientific Corporation Torflex Transseptal Guiding Sheath Kit (TFK-M)
TF85-32-63-45
TORFLEX 8.5F 63CM 45DEG
TF85-32-63-55
TORFLEX 8.5F 63CM 55DEG
Used for the percutaneous introduction of various types of
cardiovascular Open, Classified |
DXF | K183655 |
| Jul 10, 2025 | Boston Scientific Corporation VersaCross Transseptal Sheath Kit (VXS)
Product Description/IDs
VXS0201
VXS 63CM/45DEG/D0 SHEATH
VXS2112
VERSACROSS SHEATH (63CM 45DEG D0)-J
Used for the percutaneous introduction of various types o Open, Classified |
DXF | K183655 |
| Jul 10, 2025 | Boston Scientific Corporation VersaCross RF Wire (VXW). Indicated for creation of an atrial septal defect in the heart.
Product ID VXW0002
Device approved and commercialized in Japan only. Open, Classified |
DXF | None listed |
| Jul 10, 2025 | Boston Scientific Corporation VersaCross Access Solution (VXSK),
Product Description and ID:
VXSK (180J RF WIRE 63CM/45DEG/D0)
VXSK0101
VXSK (180J RF WIRE 63CM/45DEG/D1)
VXSK0102
VXSK (180J RF WIRE 63CM/55DEG/D0)
VXSK0103
VXSK (1 Open, Classified |
DXF | K150709 K183655 |
| Oct 16, 2020 | Medtronic Vascular Rashkind Balloon Septostomy Catheter, 4F, Closed end, 50 cm, Pediatric, Single Lumen
Product number: 007161
GTIN: 00613994760272
The Rashkind balloon septostomy catheters are designed for creating an Terminated |
DXF | None listed |
| Oct 16, 2020 | Medtronic Vascular Rashkind Balloon Septostomy Catheter, 5F, Closed end, 50 cm, Pediatric, Single Lumen
Product number: 007160
GTIN: 00613994760265
The Rashkind balloon septostomy catheters are designed for creating an Terminated |
DXF | None listed |
| Oct 16, 2020 | Medtronic Vascular Rashkind Balloon Septostomy Catheter, 6F, Recess Balloon, Closed end, 50 cm, Pediatric, Single Lumen
Product number: 008764
GTIN: 00613994760289
The Rashkind balloon septostomy catheters are designed Terminated |
DXF | None listed |
| Apr 25, 2019 | Edwards Lifesciences, LLC Edwards Lifesciences, Miller Balloon Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830515F
Product Usage:
The Miller balloon atrioseptostomy catheter is designed for enlarging interatrial openi Terminated |
DXF | None listed |
| Apr 25, 2019 | Edwards Lifesciences, LLC Edwards Lifesciences, Fogarty Dilation Atrioseptostomy Catheter, Sterile EO, Rx Only, REF: 830705F
Product Usage: The Fogarty dilation atrioseptostomy catheter is designed for enlarging interatrial Terminated |
DXF | None listed |
| Nov 10, 2016 | Baylis Medical Corp * NRG Transseptal Needle and NRG RF Transseptal Kit.
Model/Catalogue Numbers: NRG-56-32-C0, NRG-71-C0, NRG-71-C1, NRG-89-C0, NRG-89-C1, NRG-98-C0, NRG-98-C1, NRG-98-C1-T, NRG-E-56-32-C0, and NRG-E-HF- Terminated |
DXF | K073326 |
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