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FDA 510(k)

PERCUTANEOUS BALLOON

K-Number: K832753 · 1984-10-13

ApplicantSmec, Inc.
Decision Date1984-10-13
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PERCUTANEOUS BALLOON is the device name listed in this FDA 510(k) record. The listed applicant is Smec, Inc.. It received FDA 510(k) clearance on 1984-10-13 under 510(k) number K832753. 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 PERCUTANEOUS BALLOON?

PERCUTANEOUS BALLOON is a medical device that received FDA 510(k) clearance on 1984-10-13. The listed applicant is Smec, Inc.. The 510(k) number is K832753.

When did PERCUTANEOUS BALLOON receive FDA 510(k) clearance?

PERCUTANEOUS BALLOON received FDA 510(k) clearance on 1984-10-13, under 510(k) number K832753.

Who is the listed applicant for PERCUTANEOUS BALLOON?

The FDA 510(k) record lists Smec, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PERCUTANEOUS BALLOON?

The FDA product code for PERCUTANEOUS BALLOON is DSP.

Related Clinical Trials

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.

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Other records listing Smec, Inc. 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.

K840367PRESSURE TRIGGER MOD OF SMEC INTRA-AORTK840037MODIFIED SMEC PERCUTANEOUS INTRA-AORTICK823739INTRA-AORTIC BALLOON SYSTEMK823177SMEC BALLOON SYSTEMK813355MODIFICATION OF THE PERCUTAN-BALLOONK790755SMEC BALLOON CANNULA

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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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