510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K030549Substantially Equivalent

Hi-Torque Pilot 50 Guide Wire with Hydrocoat Hydrophilic Coating, Hi-Torque Pilot 150 Guide Wire with Hydrocoat Hydrophg

Guidcorp, Temecula CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K030549 is the FDA 510(k) clearance record for HI-TORQUE PILOT 50 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE PILOT 150 GUIDE WIRE WITH HYDROCOAT HYDROPHG, a class II device, cleared for Guidcorp on under FDA product code DQX (Wire, Guide, Catheter). FDA records list one 510(k) clearance for Guidcorp. As of , FDA records show no recalls naming K030549.

Clearance record

Decision date
Received
(82 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Guidcorp 26531 Ynez Rd., Temecula 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