DXF
HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- Advisory panel
- Cardiovascular
- Total cleared
- 20
Adverse events under product code DXF
product code DXF- Death
- 78
- Injury
- 1,126
- Malfunction
- 507
- Other
- 1
- Total
- 1,712
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recent clearances under product code DXF
- K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- K260292 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K252419 — HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)
- K251007 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C, CW-1085C, CW-1085V, CW-1013F)
- K243193 — Cross Wise Multi-Use RF Adapter Cable
- K242076 — VersaCross RF Wire
- K241414 — CrossWise RF Transseptal Access System (Models: CW-1085S, CW-1085A, CW-1012W, CW-1012C); CrossWise RF Adapter Cable (Model CW-1002)
- K240900 — HOTWIRE RF Guidewire
- K232852 — Cross Vascular RF Transseptal Needle, Cross Vascular Connection Cable
- K221528 — Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter
- K211910 — Z-6 Atrioseptostomy Catheter
- K182399 — Park Blade Septostomy Catheter
- K150709 — ProTrack RF Anchor Wire
- K073326 — NRG TRANSSEPTAL NEEDLE
- K031949 — TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75
- K011557 — PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS
- K990284 — BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE
- K001804 — NUMED Z-5 ATRIOSEPTOSTOMY CATHETER
- K860806 — REGULATED PRESSURE INJECTOR
- K801031 — BLADE SEPTOSTOMY CATHETER
Data sourced from openFDA. This site is unofficial and independent of the FDA.