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FDA 510(k)

THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.

K-Number: K896597 · 1990-02-12

ApplicantBoston Scientific Corp
Decision Date1990-02-12
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corp. It received FDA 510(k) clearance on 1990-02-12 under 510(k) number K896597. 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 THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.?

THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. is a medical device that received FDA 510(k) clearance on 1990-02-12. The listed applicant is Boston Scientific Corp. The 510(k) number is K896597.

When did THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. receive FDA 510(k) clearance?

THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. received FDA 510(k) clearance on 1990-02-12, under 510(k) number K896597.

Who is the listed applicant for THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.?

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

What is the FDA product code for THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH.?

The FDA product code for THE SIDEWINDER 40CC DL INTRA-AORTIC BALLOON CATH. is DSP.

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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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