510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K896108Substantially Equivalent

The Pilot Scimed Torque Device

Scimed Life Systems, Inc., Maple Grove MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896108 is the FDA 510(k) clearance record for THE PILOT SCIMED TORQUE DEVICE, a class II device, cleared for Scimed Life Systems, Inc. on under FDA product code LOX (Catheters, Transluminal Coronary Angioplasty, Percutaneous). FDA's definition for product code LOX reads: "A PTCA catheter is a device that operates on the principle of hydraulic pressurization applied through an inflatable balloon attached to the distal end". FDA records list 109 510(k) clearances for Scimed Life Systems, Inc., from to . As of , FDA records show no recalls naming K896108.

Clearance record

Decision date
Received
(78 days to decision)
Product code
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Regulation
21 CFR 870.5100
Device class
Class II
Review panel
Cardiovascular
Applicant
Scimed Life Systems, Inc. 6655 Wedgwood Rd., Maple Grove MN
Third party review
No

Clearances, product code LOX

Trailing 12 months
6 clearances under product code LOX in the twelve months to November 2026, April 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LOX, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20261
April 20262
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260
November 20260