Catheter, Septostomy
FDA product code DXF · 20 cleared devices
Class 2
Cardiovascular
- Regulation
- 21 CFR 870.5175
- Review panel
- CV
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1980-07-28 – 2026-06-26
DXF
2026-06-26
DXF
2026-03-13
SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
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DXF
2026-02-27
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
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DXF
2025-08-27
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
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DXF
2025-05-01
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
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DXF
2024-11-26
Cross Wise™ Multi-Use RF Adapter Cable
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DXF
2024-11-01
VersaCross™ RF Wire
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DXF
2024-09-26
CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)
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DXF
2024-05-01
HOTWIRE™ RF Guidewire
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DXF
2023-10-12
Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
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DXF
2022-08-22
Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
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DXF
2021-07-19
Z-6 Atrioseptostomy Catheter
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DXF
2019-04-04
Park Blade Septostomy Catheter
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DXF
2008-05-28
NRG TRANSSEPTAL NEEDLE
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DXF
2003-12-10
TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
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DXF
2001-07-12
PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
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DXF
2001-02-01
BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
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DXF
2000-07-12
NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
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DXF
1986-03-31
REGULATED PRESSURE INJECTOR
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DXF
1980-07-28
BLADE SEPTOSTOMY CATHETER
View details →No matching devices.
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