HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)— 510(k) K260292
Substantially EquivalentAtraverse Medical
FDA 510(k) clearance K260292 for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX), Substantially Equivalent on 2026-02-27. Applicant: Atraverse Medical. Device class: 2.
Summary
Atraverse Medical lists two entries for the HOTWIRE RF GUIDEWIRE, one marked 901XXX and one marked 902XXX. It's filed under product code DXF, septostomy catheter. The record doesn't say how the two entries differ.
Class II, 21 CFR 870.5175. Cardiovascular is both the classification panel and the review panel. It came in as a Special 510(k). The record flags it as a third-party review.
Atraverse Medical filed from Cardiff By The Sea, California. Review took 29 calendar days (January 29 to February 27, 2026), ending in a substantially equivalent decision.
Clearance details
- Applicant
- Atraverse Medical
- Product code
- Product code DXF
- Device class
- Class 2
- Regulation
- 21 CFR 870.5175
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Cardiff By The Sea, CA, US
Recent devices under product code DXF
view all- K261745 — LightningWire Transseptal Puncture System (TPS)
- K253799 — SafeSept RF Transseptal Guidewire (SSRF132; SSRF132R; SSRF232; SSRF232R; SSRF135; SSRF135R; SSRF235; SSRF235R)
- 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
More clearances from Atraverse Medical
view allAdverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.