510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K113103Substantially Equivalent

Splitwire Percutaneous Transluminal Angioplasty Scoring Device

Rex Medical LP, Great Neck NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K113103 is the FDA 510(k) clearance record for SPLITWIRE PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY SCORING DEVICE, a class II device, cleared for Rex Medical 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 21 510(k) clearances for Rex Medical, from to . As of , FDA records show no recalls naming K113103.

Clearance record

Decision date
Received
(216 days to decision)
Product code
PNO Catheter, Percutaneous, Cutting/Scoring
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Rex Medical 55 Northern Blvd., Suite 200, Great Neck NY
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