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
SUBSCRIBE / SIGN IN
DEN240017Unknown

ShortCut

PI-Cardia Ltd, Rehovot, IL / Direct, Unknown
FDA source (opens on fda.gov)

DEN240017 is the FDA 510(k) clearance record for ShortCut, a class II device, cleared for Pi-Cardia, Ltd. on under FDA product code SCZ (Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures). FDA's definition for product code SCZ reads: "The device is a single use percutaneous catheter system intended for mechanically splitting aortic valve leaflets that may prevent coronary artery ostia obstruction during planned transcatheter valve procedures". FDA records list one 510(k) clearance for Pi-Cardia, Ltd. As of , FDA records show no recalls naming DEN240017.

Clearance record

Decision date
Received
(163 days to decision)
Product code
SCZ Percutaneous Catheter For Cutting Or Splitting Heart Valve Leaflets Concomitant To Transcatheter Valve Procedures
Regulation
21 CFR 870.1254
Device class
Class II
Review panel
Cardiovascular
Applicant
Pi-Cardia, Ltd. 5 David Fikes St., Rehovot, IL
Third party review
No

Clearances, product code SCZ

Trailing 12 months

FDA records hold no clearances under product code SCZ in the trailing twelve months.

FDA records show no clearances under product code SCZ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code SCZ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260