510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K193576Substantially Equivalent

Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device)

Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193576 is the FDA 510(k) clearance record for Solitaire Platinum Revascularization Device, Solitaire X Revascularization Device (Solitaire Revascularization Device), a class II device, cleared for Micro Therapeutics, Inc. d/b/a ev3 Neurovascular on under FDA product code POL (Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment). FDA's definition for product code POL reads: "A neurovascular mechanical thrombectomy device for acute ischemic stroke treatment is a prescription device used in the treatment of acute ischemic stroke to improve clinical outcomes. The device is delivered into the neurovasculature with...". FDA records list 32 510(k) clearances for Micro Therapeutics, Inc. d/b/a ev3 Neurovascular, from to . As of , FDA records show no recalls naming K193576.

Clearance record

Decision date
Received
(333 days to decision)
Product code
POL Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment
Regulation
21 CFR 882.5600
Device class
Class II
Review panel
Neurology
Applicant
Micro Therapeutics, Inc. d/b/a ev3 Neurovascular 9775 Toledo Way, Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code POL

Trailing 12 months

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

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