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FDA 510(k)

INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION

K-Number: K940231 · 1994-09-13

ApplicantDatascope Corp.
Decision Date1994-09-13
Product CodeDSP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION is the device name listed in this FDA 510(k) record. The listed applicant is Datascope Corp.. It received FDA 510(k) clearance on 1994-09-13 under 510(k) number K940231. 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 FOR OPTIONAL SHEATHLESS INSERTION?

INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION is a medical device that received FDA 510(k) clearance on 1994-09-13. The listed applicant is Datascope Corp.. The 510(k) number is K940231.

When did INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION receive FDA 510(k) clearance?

INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION received FDA 510(k) clearance on 1994-09-13, under 510(k) number K940231.

Who is the listed applicant for INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION?

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 FOR OPTIONAL SHEATHLESS INSERTION?

The FDA product code for INTRA-AORTIC BALLOON FOR OPTIONAL SHEATHLESS INSERTION is DSP.

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Other records listing Datascope Corp. 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.

K190884TigerPaw Pro Left Atrial Appendage Occlusion Fastener And Delivery ToolK181122CARDIOSAVE Intra-Aortic Balloon PumpK172305CS100/CS100i Intra-Aortic Balloon Pump, CS300 Intra-Aortic Balloon PumpK163542CARDIOSAVE Hybrid and Rescue Intra-Aortic Balloon Pump, CARDIOSAVE Li-Ion Battery Transport and Storage CaseK133074MEGA 8FR. 50CC AND SENSATION PLUS 8FR. 50CC INTRA-AORTIC BALLOON CATHETERS AND ACCESSORIESK071805NETGUARD AUTOMATED CLINICIAN ALERT SYSTEM, MODEL 0998-00-1600-XX

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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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