510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K123452Substantially Equivalent

Tracker-17 Microcather, 150 Cm Long and 15.0 Cm Flexible Distal Shaft, Tracker-17 Microcatheter, 150 Cm Long and 7.5 Cm

Stryker Corp., Fremont CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K123452 is the FDA 510(k) clearance record for TRACKER-17 MICROCATHER, 150 CM LONG AND 15.0 CM FLEXIBLE DISTAL SHAFT, TRACKER-17 MICROCATHETER, 150 CM LONG AND 7.5 CM, a class II device, cleared for Stryker on under FDA product code DQY (Catheter, Percutaneous). FDA records list 568 510(k) clearances for Stryker, from to . As of , FDA records show no recalls naming K123452.

Clearance record

Decision date
Received
(56 days to decision)
Product code
DQY Catheter, Percutaneous
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Stryker 47900 Bayside Pkwy., Fremont CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DQY

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