510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K903621Substantially Equivalent

Magnum-20 (Tm) Inflation Device

Vascumed Systems, Amherst NH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K903621 is the FDA 510(k) clearance record for MAGNUM-20 (TM) INFLATION DEVICE, a class II device, cleared for Vascumed Systems on under FDA product code MAV (Syringe, Balloon Inflation). FDA records list 2 510(k) clearances for Vascumed Systems, from to . As of , FDA records show no recalls naming K903621.

Clearance record

Decision date
Received
(134 days to decision)
Product code
MAV Syringe, Balloon Inflation
Regulation
21 CFR 870.1650
Device class
Class II
Review panel
Cardiovascular
Applicant
Vascumed Systems 5 Norther Blvd., Amherst NH
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