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FDA 510(k)

NEWCHILL(TM) CARDIAC INSULATOR

K-Number: K892804 · 1989-07-14

ApplicantAcacia Laboratories, Inc.
Decision Date1989-07-14
Product CodeDWS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NEWCHILL(TM) CARDIAC INSULATOR is the device name listed in this FDA 510(k) record. The listed applicant is Acacia Laboratories, Inc.. It received FDA 510(k) clearance on 1989-07-14 under 510(k) number K892804. The device is classified under product code DWS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEWCHILL(TM) CARDIAC INSULATOR?

NEWCHILL(TM) CARDIAC INSULATOR is a medical device that received FDA 510(k) clearance on 1989-07-14. The listed applicant is Acacia Laboratories, Inc.. The 510(k) number is K892804.

When did NEWCHILL(TM) CARDIAC INSULATOR receive FDA 510(k) clearance?

NEWCHILL(TM) CARDIAC INSULATOR received FDA 510(k) clearance on 1989-07-14, under 510(k) number K892804.

Who is the listed applicant for NEWCHILL(TM) CARDIAC INSULATOR?

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

What is the FDA product code for NEWCHILL(TM) CARDIAC INSULATOR?

The FDA product code for NEWCHILL(TM) CARDIAC INSULATOR is DWS.

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Other records listing Acacia Laboratories, Inc. as applicant

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Related Devices (Code: DWS)

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.

K022238MYOCARDIAL LEAD IMPLANT TOOL, MODEL 10626Medtronic VascularK964445OCTOPUS TISSUE STABILIZER (28001/28002/28003/28004/28005/28006)Dlp, Inc.K962771BURKE CONGENITAL THORACOSCOPY INSTRUMENTSPilling Weck, Inc.K955689RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAYContour Fabricators of Florida, Inc.K960139G.E. STERILE ANGIOGRAPHIC TRAYGE Medical SystemsK960144G.E. STERILE CT BIOPSY TRAYGE Medical Systems

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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