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FDA 510(k)

MODIFICATION OF THE PERCUTAN-BALLOON

K-Number: K813355 · 1982-07-02

ApplicantSmec, Inc.
Decision Date1982-07-02
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFICATION OF THE PERCUTAN-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 1982-07-02 under 510(k) number K813355. 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 MODIFICATION OF THE PERCUTAN-BALLOON?

MODIFICATION OF THE PERCUTAN-BALLOON is a medical device that received FDA 510(k) clearance on 1982-07-02. The listed applicant is Smec, Inc.. The 510(k) number is K813355.

When did MODIFICATION OF THE PERCUTAN-BALLOON receive FDA 510(k) clearance?

MODIFICATION OF THE PERCUTAN-BALLOON received FDA 510(k) clearance on 1982-07-02, under 510(k) number K813355.

Who is the listed applicant for MODIFICATION OF THE PERCUTAN-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 MODIFICATION OF THE PERCUTAN-BALLOON?

The FDA product code for MODIFICATION OF THE PERCUTAN-BALLOON is DSP.

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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-AORTICK832753PERCUTANEOUS BALLOONK823739INTRA-AORTIC BALLOON SYSTEMK823177SMEC BALLOON SYSTEMK790755SMEC 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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