510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K121301Substantially Equivalent

Xpressway Rx Catheter (6F Ld-Verison)

Kaneka Pharma America, LLC, New York NY / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K121301 is the FDA 510(k) clearance record for XPRESSWAY RX CATHETER (6F LD-VERISON), a class II device, cleared for Kaneka Pharma America, LLC on under FDA product code QEZ (Aspiration Thrombectomy Catheter). FDA's definition for product code QEZ reads: "To remove thrombus from the peripheral and/or coronary vasculature through aspiration". FDA records list 4 510(k) clearances for Kaneka Pharma America, LLC, from to . As of , FDA records show no recalls naming K121301.

Clearance record

Decision date
Received
(90 days to decision)
Product code
QEZ Aspiration Thrombectomy Catheter
Regulation
21 CFR 870.5150
Device class
Class II
Review panel
Cardiovascular
Applicant
Kaneka Pharma America, LLC 546 Fifth Ave., 21st Floor, New York NY
510(k) summary
Statement
Third party review
No

Clearances, product code QEZ

Trailing 12 months
7 clearances under product code QEZ in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QEZ, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20261
April 20261
May 20260
June 20260
July 20262
August 20260
September 20261
October 20260