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FDA 510(k)

CARDIAC INSULATION PAD

K-Number: K781990 · 1978-12-04

ApplicantShiley, Inc.
Decision Date1978-12-04
Product CodeDWF
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIAC INSULATION PAD is the device name listed in this FDA 510(k) record. The listed applicant is Shiley, Inc.. It received FDA 510(k) clearance on 1978-12-04 under 510(k) number K781990. The device is classified under product code DWF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIAC INSULATION PAD?

CARDIAC INSULATION PAD is a medical device that received FDA 510(k) clearance on 1978-12-04. The listed applicant is Shiley, Inc.. The 510(k) number is K781990.

When did CARDIAC INSULATION PAD receive FDA 510(k) clearance?

CARDIAC INSULATION PAD received FDA 510(k) clearance on 1978-12-04, under 510(k) number K781990.

Who is the listed applicant for CARDIAC INSULATION PAD?

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 CARDIAC INSULATION PAD?

The FDA product code for CARDIAC INSULATION PAD is DWF.

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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: DWF)

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.

K260195Elongated One-Piece Arterial (EOPA) 3D™ Arterial CannulaeMedtronic, Inc.K250937Venous Return CannulaeLivaNova USA, Inc.K260043Smart Reactors Camouflage Coated Extracorporeal Cardiopulmonary Tubing Set (SR180C)Smart ReactorsK253203Retrograde Coronary Sinus Perfusion CannulaeMedtronic, Inc.K253671Dual Stage Venous CannulaeSorin Group Italia S.R.L.K253998Clearview Intracoronary ShuntsMedtronic, Inc.

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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