510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211807Substantially Equivalent

Sapphire NC 24

OrbusNeich Medical (Shenzhen) Co., Ltd., Shenzhen, CN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211807 is the FDA 510(k) clearance record for Sapphire NC 24, a class II device, cleared for OrbusNeich Medical (Shenzhen) Co., Ltd. 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 9 510(k) clearances for OrbusNeich Medical (Shenzhen) Co., Ltd., from to . As of , FDA records show no recalls naming K211807.

Clearance record

Decision date
Received
(125 days to decision)
Product code
LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Regulation
21 CFR 870.5100
Device class
Class II
Review panel
Cardiovascular
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd. #1 Jinkui Rd., Futian Free Trade Zone, Shenzhen, CN
510(k) summary
Summary PDF
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