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FDA 510(k)

BAIM CORONARY SINUS FLOW CALCULATOR

K-Number: K842831 · 1984-08-27

ApplicantElectro-Catheter Corp.
Decision Date1984-08-27
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

BAIM CORONARY SINUS FLOW CALCULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Electro-Catheter Corp.. It received FDA 510(k) clearance on 1984-08-27 under 510(k) number K842831. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BAIM CORONARY SINUS FLOW CALCULATOR?

BAIM CORONARY SINUS FLOW CALCULATOR is a medical device that received FDA 510(k) clearance on 1984-08-27. The listed applicant is Electro-Catheter Corp.. The 510(k) number is K842831.

When did BAIM CORONARY SINUS FLOW CALCULATOR receive FDA 510(k) clearance?

BAIM CORONARY SINUS FLOW CALCULATOR received FDA 510(k) clearance on 1984-08-27, under 510(k) number K842831.

Who is the listed applicant for BAIM CORONARY SINUS FLOW CALCULATOR?

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

What is the FDA product code for BAIM CORONARY SINUS FLOW CALCULATOR?

The FDA product code for BAIM CORONARY SINUS FLOW CALCULATOR is DXG.

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Other records listing Electro-Catheter Corp. as applicant

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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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