510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K241478Substantially Equivalent

Tri-Wedge PTA Scoring Balloon Dilatation Catheter

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

K241478 is the FDA 510(k) clearance record for Tri-Wedge PTA Scoring Balloon Dilatation Catheter, a class II device, cleared for Brosmed Medical Co., Ltd. on under FDA product code PNO (Catheter, Percutaneous, Cutting/Scoring). FDA's definition for product code PNO reads: "To reduce vascular stenosis by dilatation and apposition of the cutting/scoring surfaces to the stenotic material". FDA records list 10 510(k) clearances for Brosmed Medical Co., Ltd., from to . As of , FDA records show no recalls naming K241478.

Clearance record

Decision date
Received
(151 days to decision)
Product code
PNO Catheter, Percutaneous, Cutting/Scoring
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Brosmed Medical Co., Ltd. 15th Bldg., Smes Venture Park Songshan Lake Hi-Tech, Dongguan, 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