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FDA 510(k)

CTS MIDCAB STITCHER

K-Number: K963965 · 1998-03-17

ApplicantCardiothoracic Systems, Inc.
Decision Date1998-03-17
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CTS MIDCAB STITCHER 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 1998-03-17 under 510(k) number K963965. 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 STITCHER?

CTS MIDCAB STITCHER is a medical device that received FDA 510(k) clearance on 1998-03-17. The listed applicant is Cardiothoracic Systems, Inc.. The 510(k) number is K963965.

When did CTS MIDCAB STITCHER receive FDA 510(k) clearance?

CTS MIDCAB STITCHER received FDA 510(k) clearance on 1998-03-17, under 510(k) number K963965.

Who is the listed applicant for CTS MIDCAB STITCHER?

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 STITCHER?

The FDA product code for CTS MIDCAB STITCHER is GEI.

Related Clinical Trials

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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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/MISTERK970638CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNTK963503CTS MIDCAB 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.

K261959Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Push Button Switch (0703-046-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Push Button Switch, Bulk Non-Sterile (0703-046-102);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, 70mm Blade, Rocker Switch (0703-047-100);Neptune® SafeAir® 10ft Smoke Evacuation Pencil, Square Coated, Rocker Switch, Bulk Non-Sterile (0703-047-102)Stryker InstrumentsK254196HARMONIC 1100 Shears (HAR1120); HARMONIC 1100 Shears (HAR1136)Ethicon Endo-Surgery, LLCK261070LigaSure™ RAS Maryland Jaw Vessel Sealer/Divider, Nano-coatedCovidien, LLCK254185Potenza PrimeJeisys Medical IncorporatedK262364Ellian Enigma RF DeviceEllian CorpK253859Scarlet Pro (Scarlet Pro)VIOL Co., Ltd.

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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