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FDA 510(k)

SMEC BALLOON SYSTEM

K-Number: K823177 · 1982-12-15

ApplicantSmec, Inc.
Decision Date1982-12-15
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMEC BALLOON SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Smec, Inc.. It received FDA 510(k) clearance on 1982-12-15 under 510(k) number K823177. 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 SMEC BALLOON SYSTEM?

SMEC BALLOON SYSTEM is a medical device that received FDA 510(k) clearance on 1982-12-15. The listed applicant is Smec, Inc.. The 510(k) number is K823177.

When did SMEC BALLOON SYSTEM receive FDA 510(k) clearance?

SMEC BALLOON SYSTEM received FDA 510(k) clearance on 1982-12-15, under 510(k) number K823177.

Who is the listed applicant for SMEC BALLOON SYSTEM?

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 SMEC BALLOON SYSTEM?

The FDA product code for SMEC BALLOON SYSTEM 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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 SYSTEMK813355MODIFICATION OF THE PERCUTAN-BALLOONK790755SMEC BALLOON CANNULA

View all 7 devices →

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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