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FDA 510(k)

CTS MIDCAB/SVH BIPOLAR SCISSORS

K-Number: K963930 · 1997-01-16

ApplicantCardiothoracic Systems, Inc.
Decision Date1997-01-16
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CTS MIDCAB/SVH BIPOLAR SCISSORS is the device name listed in this FDA 510(k) record. The listed applicant is Cardiothoracic Systems, Inc.. It received FDA 510(k) clearance on 1997-01-16 under 510(k) number K963930. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CTS MIDCAB/SVH BIPOLAR SCISSORS?

CTS MIDCAB/SVH BIPOLAR SCISSORS is a medical device that received FDA 510(k) clearance on 1997-01-16. The listed applicant is Cardiothoracic Systems, Inc.. The 510(k) number is K963930.

When did CTS MIDCAB/SVH BIPOLAR SCISSORS receive FDA 510(k) clearance?

CTS MIDCAB/SVH BIPOLAR SCISSORS received FDA 510(k) clearance on 1997-01-16, under 510(k) number K963930.

Who is the listed applicant for CTS MIDCAB/SVH BIPOLAR SCISSORS?

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

What is the FDA product code for CTS MIDCAB/SVH BIPOLAR SCISSORS?

The FDA product code for CTS MIDCAB/SVH BIPOLAR SCISSORS is GEI.

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Other records listing Cardiothoracic Systems, 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.

K010117GUIDANT AXIUS CORONARY SHUNTK983270VOYAGER QUAD CANNULAK982419HEART-LIFT BALLOON POSITIONERK983135BLOWER/MISTERK963965CTS MIDCAB STITCHERK970638CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT

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Related Devices (Code: GEI)

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.

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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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