510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210282Substantially Equivalent

WIRION Embolic Protection System

Cardiovascular Systems Incorporated, St.Paul MN / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210282 is the FDA 510(k) clearance record for WIRION Embolic Protection System, a class II device, cleared for Cardiovascular Systems, Inc. on under FDA product code NTE (Temporary Carotid Catheter For Embolic Capture). FDA's definition for product code NTE reads: "This device is a single use percutaneous catheter system that is introduced into an artery through the skin using a guidewire. The catheter has an embolic capture filter or an occlusion balloon at the distal end. The filter or balloon can...". FDA records list 28 510(k) clearances for CARDIOVASCULAR SYSTEMS INCORPORATED, from to . As of , FDA records show one recall naming K210282.

Clearance record

Decision date
Received
(30 days to decision)
Product code
NTE Temporary Carotid Catheter For Embolic Capture
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Cardiovascular Systems, Inc. 1225 Old Hwy. 8 NW, St.Paul MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NTE

Trailing 12 months

FDA records hold no clearances under product code NTE in the trailing twelve months.

FDA records show no clearances under product code NTE in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NTE, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260