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
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K192318Substantially Equivalent

Ultraverse 014 and 018 PTA Balloon Dilatation Catheters

Bard Peripheral Vascular Inc, Tempe AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K192318 is the FDA 510(k) clearance record for Ultraverse 014 and 018 PTA Balloon Dilatation Catheters, a class II device, cleared for Bard Peripheral Vascular, Inc. on under FDA product code LIT (Catheter, Angioplasty, Peripheral, Transluminal). FDA records list 39 510(k) clearances for Bard Peripheral Vascular, Inc., from to . As of , FDA records show no recalls naming K192318.

Clearance record

Decision date
Received
(38 days to decision)
Product code
LIT Catheter, Angioplasty, Peripheral, Transluminal
Regulation
21 CFR 870.1250
Device class
Class II
Review panel
Cardiovascular
Applicant
Bard Peripheral Vascular, Inc. 1625 W. 3rd St., Tempe AZ
510(k) summary
Summary PDF
Third party review
Yes

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