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FDA 510(k)

BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP

K-Number: K982538 · 1998-10-02

ApplicantBelmont Instrument Corp.
Decision Date1998-10-02
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP is the device name listed in this FDA 510(k) record. The listed applicant is Belmont Instrument Corp.. It received FDA 510(k) clearance on 1998-10-02 under 510(k) number K982538. The device is classified under product code DSP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP?

BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP is a medical device that received FDA 510(k) clearance on 1998-10-02. The listed applicant is Belmont Instrument Corp.. The 510(k) number is K982538.

When did BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP receive FDA 510(k) clearance?

BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP received FDA 510(k) clearance on 1998-10-02, under 510(k) number K982538.

Who is the listed applicant for BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP?

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

What is the FDA product code for BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP?

The FDA product code for BELMONT PORTABLE BALLOON PUMP, BARD TRANSACT IABP is DSP.

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Other records listing Belmont Instrument Corp. as applicant

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.

K131519BELMONT HYPERTHERMIA PUMPK112639THE BELMONT BUDDY LITE FLUID WARMERK091855THE BELMONT FLUID MANAGEMENT SYSTEM/ THE BELMONT RAPID INFUSER, MODEL FMS2000K090508THE BELMONT BUDDY LITE FLUID WARMERK090089BELMONT HYPERTHERMIA PUMPK070654HYPERTHERMIA PUMP

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Related Devices (Code: DSP)

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.

K250542AC3™ Range™ Intra-Aortic Balloon PumpArrow International, LLCK232343AC3™ Series IABPArrow International, LLCK201112AC3 IABP, AC3 Optimus IABP, AutoCAT2 Wave IABP, AutoCAT2 IABPArrow International, Inc.K200634Arrow FiberOptix Intra-Aortic Balloon Catheter KitArrow International, Inc.K192238AC3 Series Intra-Aortic Balloon Pump (IABP)Arrow International, TeleflexK190101UltraFlex IABArrow International, 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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