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FDA 510(k)

CATHETER BALLOON DILATOR PRESSURE GAUGE

K-Number: K895511 · 1990-02-28

ApplicantArgon Medical Corp.
Decision Date1990-02-28
Product CodeMAV
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CATHETER BALLOON DILATOR PRESSURE GAUGE is the device name listed in this FDA 510(k) record. The listed applicant is Argon Medical Corp.. It received FDA 510(k) clearance on 1990-02-28 under 510(k) number K895511. 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 CATHETER BALLOON DILATOR PRESSURE GAUGE?

CATHETER BALLOON DILATOR PRESSURE GAUGE is a medical device that received FDA 510(k) clearance on 1990-02-28. The listed applicant is Argon Medical Corp.. The 510(k) number is K895511.

When did CATHETER BALLOON DILATOR PRESSURE GAUGE receive FDA 510(k) clearance?

CATHETER BALLOON DILATOR PRESSURE GAUGE received FDA 510(k) clearance on 1990-02-28, under 510(k) number K895511.

Who is the listed applicant for CATHETER BALLOON DILATOR PRESSURE GAUGE?

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

What is the FDA product code for CATHETER BALLOON DILATOR PRESSURE GAUGE?

The FDA product code for CATHETER BALLOON DILATOR PRESSURE GAUGE is MAV.

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Other records listing Argon Medical Corp. as applicant

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Related Devices (Code: MAV)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K260035Digital Indeflator INFLANTEUAB TelemedicinaK220773Everest 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 VascularK162272Fluent 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.

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