510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K261778Substantially Equivalent

JADE SCORE PTA Scoring Balloon Dilatation Catheter

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

Clearance record

Decision date
Received
(110 days to decision)
Product code
PNO Catheter, Percutaneous, Cutting/Scoring
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
OrbusNeich Medical (Shenzhen) Co., Ltd. #1 Jinkui Rd., Shenzhen, CN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNO

Trailing 12 months
2 clearances under product code PNO in the twelve months to October 2026, February 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PNO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20261
October 20260