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FDA 510(k)

INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION

K-Number: K923603 · 1993-03-08

ApplicantKontron Instruments, Inc.
Decision Date1993-03-08
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION is the device name listed in this FDA 510(k) record. The listed applicant is Kontron Instruments, Inc.. It received FDA 510(k) clearance on 1993-03-08 under 510(k) number K923603. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION?

INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-03-08. The listed applicant is Kontron Instruments, Inc.. The 510(k) number is K923603.

When did INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION receive FDA 510(k) clearance?

INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION received FDA 510(k) clearance on 1993-03-08, under 510(k) number K923603.

Who is the listed applicant for INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION?

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

What is the FDA product code for INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION?

The FDA product code for INTRA-AORTIC BALLOON PUMP CATHETER - MODIFICATION is DYB.

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Other records listing Kontron Instruments, 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.

K932268MODIFICATIONS TO INTRA-AORTIC BALLOONSK925248MODIFICATION OF INTRA-AORTIC BALLOON CATHETERSK905313KONTRON INTRA-AORTIC BALLOON PUMP, MODEL KAAT IIK9033449.5 FR PERCUTANEOUS DB LUMEN 40CC FLEXI-CATH (TM)K896437KONTRON SIGMA 44 HVCD ULTRASOUND IMAGING SYSTEMK8922229.5F PERCU DOUBLE LUMEN INTRA-AORTIC BALLOON

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Related Devices (Code: DYB)

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.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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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