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
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K260012Substantially Equivalent

UltraScore™ Focused Force PTA Balloon

Bard Peripheral Vascular Inc, Tempe AZ / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K260012 is the FDA 510(k) clearance record for UltraScore™ Focused Force PTA Balloon, a class II device, cleared for Bard Peripheral Vascular, Inc. 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 39 510(k) clearances for Bard Peripheral Vascular, Inc., from to . As of , FDA records show no recalls naming K260012.

Clearance record

Decision date
Received
(30 days to decision)
Product code
PNO Catheter, Percutaneous, Cutting/Scoring
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Bard Peripheral Vascular, Inc. 1625 W. 3rd St., Tempe AZ
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