510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K162384Substantially Equivalent

TrailBlazer Angled Support Catheter

Medtronic Vascular, Inc.(Formerly Ev3 Inc.), Plymouth MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K162384 is the FDA 510(k) clearance record for TrailBlazer Angled Support Catheter, a class II device, cleared for Medtronic Vascular, Inc.(Formerly Ev3 Inc.) on under FDA product code DQY (Catheter, Percutaneous). FDA records list one 510(k) clearance for Medtronic Vascular, Inc.(Formerly Ev3 Inc.). As of , FDA records show no recalls naming K162384.

Clearance record

Decision date
Received
(28 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Vascular, Inc.(Formerly Ev3 Inc.) 3033 Campus Dr., Plymouth MN
510(k) summary
Summary PDF
Third party review
Yes

Clearances, product code DQY

Trailing 12 months
13 clearances under product code DQY in the twelve months to October 2026, July 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code DQY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20260
March 20261
April 20262
May 20260
June 20262
July 20263
August 20262
September 20261
October 20260