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FDA 510(k)

FLEXIBLE INTRACARDIAC SUCTION DEVICE

K-Number: K905008 · 1991-01-23

ApplicantGish Biomedical, Inc.
Decision Date1991-01-23
Product CodeDTS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FLEXIBLE INTRACARDIAC SUCTION DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Gish Biomedical, Inc.. It received FDA 510(k) clearance on 1991-01-23 under 510(k) number K905008. The device is classified under product code DTS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLEXIBLE INTRACARDIAC SUCTION DEVICE?

FLEXIBLE INTRACARDIAC SUCTION DEVICE is a medical device that received FDA 510(k) clearance on 1991-01-23. The listed applicant is Gish Biomedical, Inc.. The 510(k) number is K905008.

When did FLEXIBLE INTRACARDIAC SUCTION DEVICE receive FDA 510(k) clearance?

FLEXIBLE INTRACARDIAC SUCTION DEVICE received FDA 510(k) clearance on 1991-01-23, under 510(k) number K905008.

Who is the listed applicant for FLEXIBLE INTRACARDIAC SUCTION DEVICE?

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

What is the FDA product code for FLEXIBLE INTRACARDIAC SUCTION DEVICE?

The FDA product code for FLEXIBLE INTRACARDIAC SUCTION DEVICE is DTS.

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Other records listing Gish Biomedical, 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.

K090449MEDOS HILITE INFANT OXYGENATOR, MODEL 1000, 800 LTK090450MEDOS HILITE PEDIATRIC OXYGENATOR, MODELS 2800, 2400 LTK091062MEDOS HILITE INFANT RESERVOIR, MODEL MVC 0730K083131MEDOS HILITE RESERVOIR, MODEL: 4030K082403MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LTK082082GISH SVR SOFT VENOUS RESERVOIRS WITH HA COATING

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Related Devices (Code: DTS)

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.

K053021ESTECH CLEARVIEW MV ATRIAL DEPRESSOREstech, Inc.K982891CALIFORNIA MEDICAL LABORATORIES INC. STANDARD AND SMALL RIGID TIP SUCTION WANDSCalifornia Medical Laboratories, Inc.K963756IBC CARDIAC SUCTION WARDInternational Biophysics Corp.K900339HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLESShiley, Inc.K891906ROBICSEK INTRACARDIAC SUCTION WANDGish Biomedical, Inc.K801641OHIO DISPOSABLE CLEAR SUCTION INSTRUMENTOhio Medical Products

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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