510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K861847Substantially Equivalent

Acs Rotating Hemo Valve - Dual Access Type

Advanced Cardiovascular Systems, Inc., Temecula CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861847 is the FDA 510(k) clearance record for ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE, a class II device, cleared for Advanced Cardiovascular 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 103 510(k) clearances for Advanced Cardiovascular Systems, Inc., from to . As of , FDA records show 2 recalls naming K861847.

Clearance record

Decision date
Received
(34 days to decision)
Product code
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Regulation
21 CFR 870.5100
Device class
Class II
Review panel
Cardiovascular
Applicant
Advanced Cardiovascular Systems, Inc. 26531 Ynez Rd., Temecula CA
Third party review
No

Clearances, product code LOX

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