Home / 510(k) Clearances / K040138

510(k) K040138

VICEROY INFLATION DEVICE by Merit Medical Systems, Inc. — Product Code MAV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 2004
Date Received
January 22, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Syringe, Balloon Inflation
Device Class
Class II
Regulation Number
870.1650
Review Panel
CV
Submission Type

Other clearances by Merit Medical Systems, Inc.

  • K251802 — STAR RF Ablation System (February 13, 2026)
  • K252892 — SCOUT MD Surgical Guidance System (December 19, 2025)
  • K250853 — Merit Syringe (November 4, 2025)
  • K251265 — Resilience Fully Covered Esophageal Stent System (July 23, 2025)
  • K250909 — Prelude Wave Hydrophilic Sheath Introducer (April 25, 2025)
  • K242873 — Ventrax™ Delivery System (January 15, 2025)
  • K242229 — Micro Ace Gold Advanced Micro Access System (January 15, 2025)
  • K241521 — Prelude Small O.D. Introducer Guide Wire (December 10, 2024)
  • K233268 — Impress Angiographic Catheter (May 22, 2024)
  • K240261 — Siege Vascular Plug (SVP2.5-0.021); Siege Vascular Plug (SVP4-0.021); Siege Vasc (May 2, 2024)

Other clearances for product code MAV

  • K220773 — Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Dev (April 13, 2022)
  • K162272 — Fluent inflation device (October 20, 2016)
  • K153038 — Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disp (April 13, 2016)
  • K153672 — basixTOUCH40 Inflation Syringe (January 20, 2016)
  • K152387 — Fluent Inflation Device (December 18, 2015)
  • K140943 — MASTRO PLUS BALLOON IN-DEFLATION DEVICE (March 5, 2015)
  • K143522 — Presto Inflation Device (January 12, 2015)
  • K133795 — SUMMED INFLATION DEVICE KIT (December 12, 2014)
  • K140745 — ENCORE 26 ADVANTAGE KIT (April 17, 2014)
  • K130566 — BASIXTOUCH (June 19, 2013)