510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053195Substantially Equivalent

Spiderx Embolic Protection Device

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

K053195 is the FDA 510(k) clearance record for SPIDERX EMBOLIC PROTECTION DEVICE, a class II device, cleared for Ev3, Inc. on under FDA product code NFA (Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show no recalls naming K053195.

Clearance record

Decision date
Received
(220 days to decision)
Product code
NFA Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Ev3, Inc. 4600 Nathan Ln. N, Plymouth MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NFA

Trailing 12 months

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

FDA records show no clearances under product code NFA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NFA, 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