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
K121083Substantially Equivalent

True Dilatation Percutaneous Transluminal Valvuloplasty Catheter, 20Mm X 4.5Cm, True Dilatation Percutaneous Translumina

Loma Vista Medical, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K121083 is the FDA 510(k) clearance record for TRUE DILATATION PERCUTANEOUS TRANSLUMINAL VALVULOPLASTY CATHETER, 20MM X 4.5CM, TRUE DILATATION PERCUTANEOUS TRANSLUMINA, a class II device, cleared for Loma Vista Medical on under FDA product code OZT (Balloon Aortic Valvuloplasty). FDA's definition for product code OZT reads: "A balloon aortic valvuloplasty catheter is indicated for balloon valvuloplasty of the aortic valve". FDA records list one 510(k) clearance for Loma Vista Medical. As of , FDA records show one recall naming K121083.

Clearance record

Decision date
Received
(184 days to decision)
Product code
OZT Balloon Aortic Valvuloplasty
Regulation
21 CFR 870.1255
Device class
Class II
Review panel
Cardiovascular
Applicant
Loma Vista Medical 1307 S. Mary Ave., Sunnyvale CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OZT

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