510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K260292Substantially Equivalent

Hotwire RF Guidewire (901Xxx); Hotwire RF Guidewire (902Xxx)

Atraverse Medical, Cardiff By The Sea CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260292 is the FDA 510(k) clearance record for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX), a class II device, cleared for Atraverse Medical on under FDA product code DXF (Catheter, Septostomy). FDA records list 4 510(k) clearances for Atraverse Medical, from to . As of , FDA records show no recalls naming K260292.

Clearance record

Decision date
Received
(29 days to decision)
Product code
DXF Catheter, Septostomy
Regulation
21 CFR 870.5175
Device class
Class II
Review panel
Cardiovascular
Applicant
Atraverse Medical 2611 S Coast Hwy. #204, Cardiff By The Sea CA
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DXF

Trailing 12 months
3 clearances under product code DXF in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DXF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260