510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K192399Substantially Equivalent

Infinity Angioplasty Balloon Catheter

Infinity Angioplasty Balloon Company, LLC, Toledo OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192399 is the FDA 510(k) clearance record for Infinity Angioplasty Balloon Catheter, a class II device, cleared for Infinity Angioplasty Balloon Company, LLC on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list one 510(k) clearance for Infinity Angioplasty Balloon Company, LLC. As of , FDA records show no recalls naming K192399.

Clearance record

Decision date
Received
(260 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Infinity Angioplasty Balloon Company, LLC 6865 N. Reynolds Rd. Suite 200, Toledo OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LIT

Trailing 12 months
5 clearances under product code LIT in the twelve months to October 2026, September 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code LIT, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20261
June 20260
July 20260
August 20260
September 20262
October 20260