510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K243601Substantially Equivalent

Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set

Route 92 Medical, Head Quarters, San Mateo CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K243601 is the FDA 510(k) clearance record for Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set, a class II device, cleared for Route 92 Medical, Inc. on under FDA product code NRY (Catheter, Thrombus Retriever). FDA's definition for product code NRY reads: "The device is intended to restore blood flow by removing thrombus/clots in patients experiencing ischemic stroke. The prior clearances in this category have been limited to simply identifying catheter placed in the peripheral, coronary...". FDA records list 14 510(k) clearances for Route 92 Medical, Head Quarters, from to . As of , FDA records show no recalls naming K243601.

Clearance record

Decision date
Received
(179 days to decision)
Product code
NRY Catheter, Thrombus Retriever
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Route 92 Medical, Inc. 155 Bovet Rd., San Mateo CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NRY

Trailing 12 months
13 clearances under product code NRY in the twelve months to October 2026, August 2026 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code NRY, trailing twelve months
MonthClearances
November 20251
December 20250
January 20261
February 20260
March 20262
April 20260
May 20262
June 20261
July 20261
August 20264
September 20261
October 20260