510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K042996Substantially Equivalent

Combowire Pressure and Flow Guide Wire, Combotip Pressure and Flow Guide Wire

Volcano Therapeutics, Inc., Rancho Cordova, CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K042996 is the FDA 510(k) clearance record for COMBOWIRE PRESSURE AND FLOW GUIDE WIRE, COMBOTIP PRESSURE AND FLOW GUIDE WIRE, a class II device, cleared for Volcano Therapeutics, Inc. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 3 510(k) clearances for Volcano Therapeutics, Inc., from to . As of , FDA records show no recalls naming K042996.

Clearance record

Decision date
Received
(23 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Volcano Therapeutics, Inc. 2870 Kilgore Rd.., Rancho Cordova, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQX

Trailing 12 months
12 clearances under product code DQX in the twelve months to October 2026, January 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQX, trailing twelve months
MonthClearances
November 20251
December 20250
January 20263
February 20260
March 20263
April 20260
May 20261
June 20260
July 20262
August 20260
September 20262
October 20260