510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K132623Substantially Equivalent

Medtronic Confida Brecker Curve Guidewire

Medtronic, Inc., Santa Rosa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132623 is the FDA 510(k) clearance record for MEDTRONIC CONFIDA BRECKER CURVE GUIDEWIRE, a class II device, cleared for Medtronic on under FDA product code DQX (Wire, Guide, Catheter). FDA records list 1,525 510(k) clearances for Medtronic, from to . As of , FDA records show no recalls naming K132623.

Clearance record

Decision date
Received
(119 days to decision)
Product code
DQX Wire, Guide, Catheter
Regulation
21 CFR 870.1330
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic 3576 Unocal Pl., Santa Rosa CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQX

Trailing 12 months
13 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 20261