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FDA 510(k)

SUPRACOR BALLOON CATHETER

K-Number: K062582 · 2006-12-14

ApplicantAbiomed, Inc.
Decision Date2006-12-14
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SUPRACOR BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Abiomed, Inc.. It received FDA 510(k) clearance on 2006-12-14 under 510(k) number K062582. 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 SUPRACOR BALLOON CATHETER?

SUPRACOR BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2006-12-14. The listed applicant is Abiomed, Inc.. The 510(k) number is K062582.

When did SUPRACOR BALLOON CATHETER receive FDA 510(k) clearance?

SUPRACOR BALLOON CATHETER received FDA 510(k) clearance on 2006-12-14, under 510(k) number K062582.

Who is the listed applicant for SUPRACOR BALLOON CATHETER?

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

What is the FDA product code for SUPRACOR BALLOON CATHETER?

The FDA product code for SUPRACOR BALLOON CATHETER 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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