COMPANY
Atraverse Medical
Generation Left-Heart Access Atraverse is developing flexible transeptal access technologies to streamline procedures and improve patient outcomes. From company website Source · Oct 12, 2026
Timeline
- FDA FDA 510(k) clearance: HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) — K260292, Feb 27, 2026. Applicant at approval: Atraverse Medical. source ↗
- FDA FDA 510(k) clearance: HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) — K252419, Aug 27, 2025. Applicant at approval: Atraverse Medical, Inc. source ↗
- FDA FDA 510(k) clearance: HOTWIRE System RF Generator and Footswitch (optional accessory) — K252083, Aug 12, 2025. Applicant at approval: Atraverse Medical, Inc. source ↗
FDA records (last 2 years)
- FDA 510(k) clearance: HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) — K260292, Feb 27, 2026. Applicant at approval: Atraverse Medical. source ↗
- FDA 510(k) clearance: HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) — K252419, Aug 27, 2025. Applicant at approval: Atraverse Medical, Inc. source ↗
- FDA 510(k) clearance: HOTWIRE System RF Generator and Footswitch (optional accessory) — K252083, Aug 12, 2025. Applicant at approval: Atraverse Medical, Inc. source ↗
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