FDA 510(k)

INFLATION/DEFLATION DEVICE

K-Number: K904394 · 1990-12-03

Decision Date1990-12-03

Product CodeMAV

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

INFLATION/DEFLATION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1990-12-03 under 510(k) number K904394. The device is classified under product code MAV. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFLATION/DEFLATION DEVICE?

INFLATION/DEFLATION DEVICE is a medical device that received FDA 510(k) clearance on 1990-12-03. The listed applicant is Boston Scientific Corp. The 510(k) number is K904394.

When did INFLATION/DEFLATION DEVICE receive FDA 510(k) clearance?

INFLATION/DEFLATION DEVICE received FDA 510(k) clearance on 1990-12-03, under 510(k) number K904394.

Who is the listed applicant for INFLATION/DEFLATION DEVICE?

The FDA 510(k) record lists Boston Scientific Corp as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for INFLATION/DEFLATION DEVICE?

The FDA product code for INFLATION/DEFLATION DEVICE is MAV.

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Related Devices (Code: MAV)

K260035Digital Indeflator INFLANTEUAB Telemedicina K220773Everest 20 Inflation Device and 3-way Stopcock (AC2200);Everest 30 Inflation Device and 3-way Stopcock (AC3200);Everest 20 Survival Kit containing:1. Everest 20 Device with 3-way Stopcock, 2. Piton Y-Adaptor ,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC2205P); Everest 30 Survival Kit containing:1. Everest 30 Device with 3-way Stopcock, 2. Piton Y-Adaptor,3. Metal Guidewire Insertion Needle, 4. Torque Handle (AC3205P)Medtronic Vascular K162272Fluent inflation deviceVascular Solutions, Inc.K153038Everest 20 Disposable Inflation Device, Everest 20 Survival Kit, Everest 30 Disposable Inflation Device, Everest 30 Survival KitMedtronic, Inc.K153672basixTOUCH40 Inflation SyringeMerit Medical Systems, Inc.K130566BASIXTOUCHMerit Medical Systems, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.