510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K121398Substantially Equivalent

Charlie Guidewire (Regular), Charlie Guidewire (Stiff)

Guidepath Medical, Inc., Austin TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121398 is the FDA 510(k) clearance record for CHARLIE GUIDEWIRE (REGULAR), CHARLIE GUIDEWIRE (STIFF), a class II device, cleared for Guidepath Medical, Inc. on under FDA product code DQX (Wire, Guide, Catheter). FDA records list one 510(k) clearance for Guidepath Medical, Inc. As of , FDA records show 12 recalls naming K121398.

Clearance record

Decision date
Received
(218 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Guidepath Medical, Inc. 2621 Ridgepoint Dr., Suite 100, Austin TX
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