510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K911295Substantially Equivalent

Angioplasty Inflator

Vastek, Dayton OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K911295 is the FDA 510(k) clearance record for ANGIOPLASTY INFLATOR, a class II device, cleared for Vastek on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list one 510(k) clearance for Vastek. As of , FDA records show no recalls naming K911295.

Clearance record

Decision date
Received
(109 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Vastek 401 E. Keowee St., Dayton OH
Third party review
No

Clearances, product code MAV

Trailing 12 months
1 clearance under product code MAV in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MAV, 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 20261
October 20260