510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K070951Substantially Equivalent

2Cm Peripheral Cutting Balloon, Small Peripheral Cutting Balloon with Monorail and Over-the-Wire Delivery Systems

Boston Scientific Corporation, San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K070951 is the FDA 510(k) clearance record for 2CM PERIPHERAL CUTTING BALLOON, SMALL PERIPHERAL CUTTING BALLOON WITH MONORAIL AND OVER-THE-WIRE DELIVERY SYSTEMS, a class II device, cleared for Boston Scientific 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 1,110 510(k) clearances for Boston Scientific, from to . As of , FDA records show no recalls naming K070951.

Clearance record

Decision date
Received
(61 days to decision)
Product code
PNO Catheter, Percutaneous, Cutting/Scoring
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Boston Scientific 3574 Ruffin Rd., San Diego CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PNO

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