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FDA 510(k)

HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES

K-Number: K900339 · 1990-03-28

ApplicantShiley, Inc.
Decision Date1990-03-28
Product CodeDTS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1990-03-28 under 510(k) number K900339. 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 HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES?

HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES is a medical device that received FDA 510(k) clearance on 1990-03-28. The listed applicant is Shiley, Inc.. The 510(k) number is K900339.

When did HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES receive FDA 510(k) clearance?

HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES received FDA 510(k) clearance on 1990-03-28, under 510(k) number K900339.

Who is the listed applicant for HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES?

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

What is the FDA product code for HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES?

The FDA product code for HAND-HELD INTRACARDIAC SUCKERS W/ERGONOMIC HANDLES is DTS.

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Other records listing Shiley, 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.

K920594SHILEY PERFUSION TUBING SETSK910991SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEMK911876SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200K910923BCD ADVANCEDK901548BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GASK903435SHILEY SPECIALIZED TRACHEOSTOMY TUBE

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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.K905008FLEXIBLE INTRACARDIAC SUCTION DEVICEGish Biomedical, 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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