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FDA 510(k)

BALADI INVERTER WITH COAXIAL AORTIC PUNCH

K-Number: K980128 · 1998-07-24

ApplicantCardio Medical Solutions, Inc.
Decision Date1998-07-24
Product CodeDXC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BALADI INVERTER WITH COAXIAL AORTIC PUNCH is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Medical Solutions, Inc.. It received FDA 510(k) clearance on 1998-07-24 under 510(k) number K980128. The device is classified under product code DXC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BALADI INVERTER WITH COAXIAL AORTIC PUNCH?

BALADI INVERTER WITH COAXIAL AORTIC PUNCH is a medical device that received FDA 510(k) clearance on 1998-07-24. The listed applicant is Cardio Medical Solutions, Inc.. The 510(k) number is K980128.

When did BALADI INVERTER WITH COAXIAL AORTIC PUNCH receive FDA 510(k) clearance?

BALADI INVERTER WITH COAXIAL AORTIC PUNCH received FDA 510(k) clearance on 1998-07-24, under 510(k) number K980128.

Who is the listed applicant for BALADI INVERTER WITH COAXIAL AORTIC PUNCH?

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

What is the FDA product code for BALADI INVERTER WITH COAXIAL AORTIC PUNCH?

The FDA product code for BALADI INVERTER WITH COAXIAL AORTIC PUNCH is DXC.

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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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