Angioplasty Inflator

FDA 510(k) K911295 · Vastek

Substantially Equivalent

510(k) numberK911295

Submission

Device name
Angioplasty Inflator
Applicant
Vastek
Dayton, OH, US
Received
March 25, 1991
Decision date
July 12, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
MAV – Syringe, Balloon Inflation
Device class
Class II (moderate risk)
Regulation
21 CFR 870.1650
Specialty
Cardiovascular

Other 510(k)s with product code MAV

510(k)DeviceApplicantDecision
K260035Digital Indeflator INFLANTEMAV · Traditional UAB Telemedicina09/04/2026SE
K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and…MAV · Special Medtronic Vascular04/13/2022SE
K162272Fluent inflation deviceMAV · Special Vascular Solutions, Inc.10/20/2016SE
K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable…MAV · Special Medtronic, Inc.04/13/2016SESK
K153672basixTOUCH40 Inflation SyringeMAV · Special Merit Medical Systems, Inc.01/20/2016SESK
K152387Fluent Inflation DeviceMAV · Traditional Vascular Solutions, Inc.12/18/2015SESK
K140943Mastro Plus Balloon In-Deflation DeviceMAV · Traditional Beijing Demax Medical Technology Co.,Ltd03/05/2015SE
K143522Presto Inflation DeviceMAV · Traditional C.R. Bard, Inc.01/12/2015SE
K133795Summed Inflation Device KitMAV · Traditional Sunny Medical Device (Shenzhen) Co., Ltd.12/12/2014SE
K140745Encore 26 Advantage KitMAV · Special Boston Scientific Corp04/17/2014SESK

Questions and answers

When was Angioplasty Inflator cleared by the FDA?

Angioplasty Inflator (K911295) received a 510(k) decision of Substantially Equivalent on July 12, 1991, 109 days after the submission was received.

What is the product code of K911295?

The FDA product code is MAV – Syringe, Balloon Inflation, a Class II (moderate risk) device regulated under 21 CFR 870.1650.