510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K913803Substantially Equivalent

Intraluminal Artery Stripper

Omni-Tract Surgical, Div. Minn. Scientific, Inc., St. Paul MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K913803 is the FDA 510(k) clearance record for INTRALUMINAL ARTERY STRIPPER, a class II device, cleared for Omni-Tract Surgical, Div. Minn. Scientific, Inc. on under FDA product code DWX (Stripper, Artery, Intraluminal). FDA records list 4 510(k) clearances for Omni-Tract Surgical, Div. Minn. Scientific, Inc., from to . As of , FDA records show no recalls naming K913803.

Clearance record

Decision date
Received
(242 days to decision)
Product code
DWX Stripper, Artery, Intraluminal
Regulation
21 CFR 870.4875
Device class
Class II
Review panel
Cardiovascular
Applicant
Omni-Tract Surgical, Div. Minn. Scientific, Inc. 403 County Rd., E2 W., St. Paul MN
510(k) summary
Statement
Third party review
No

Clearances, product code DWX

Trailing 12 months

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

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