510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K091582Substantially Equivalent

Gtx Guidewire, Models Tbd-Gtx 1, 3,6,9,12, 15

Medtronic, Inc., Danvers MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091582 is the FDA 510(k) clearance record for GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15, a class II device, cleared for Medtronic Vascular on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show one recall naming K091582.

Clearance record

Decision date
Received
(185 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Vascular 37a Cherry Hill Dr., Danvers MA
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