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FDA 510(k)

INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED

K-Number: K961509 · 1996-11-15

ApplicantDatascope Corp.
Decision Date1996-11-15
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1996-11-15 under 510(k) number K961509. 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 INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED?

INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED is a medical device that received FDA 510(k) clearance on 1996-11-15. The listed applicant is Datascope Corp.. The 510(k) number is K961509.

When did INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED receive FDA 510(k) clearance?

INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED received FDA 510(k) clearance on 1996-11-15, under 510(k) number K961509.

Who is the listed applicant for INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED?

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

What is the FDA product code for INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED?

The FDA product code for INTRA-AORTIC BALLOON PUMP SYSTEM 97 MODIFIED is DSP.

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Other records listing Datascope Corp. as applicant

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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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