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FDA 510(k)

MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC

K-Number: K840037 · 1985-02-01

ApplicantSmec, Inc.
Decision Date1985-02-01
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC is the device name listed in this FDA 510(k) record. The listed applicant is Smec, Inc.. It received FDA 510(k) clearance on 1985-02-01 under 510(k) number K840037. 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 MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC?

MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC is a medical device that received FDA 510(k) clearance on 1985-02-01. The listed applicant is Smec, Inc.. The 510(k) number is K840037.

When did MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC receive FDA 510(k) clearance?

MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC received FDA 510(k) clearance on 1985-02-01, under 510(k) number K840037.

Who is the listed applicant for MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC?

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 MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC?

The FDA product code for MODIFIED SMEC PERCUTANEOUS INTRA-AORTIC 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-AORTK832753PERCUTANEOUS BALLOONK823739INTRA-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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