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FDA 510(k)

PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET

K-Number: K874927 · 1988-01-29

ApplicantPioneering Technologies, Inc.
Decision Date1988-01-29
Product CodeDWC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET is the device name listed in this FDA 510(k) record. The listed applicant is Pioneering Technologies, Inc.. It received FDA 510(k) clearance on 1988-01-29 under 510(k) number K874927. The device is classified under product code DWC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET?

PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET is a medical device that received FDA 510(k) clearance on 1988-01-29. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K874927.

When did PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET receive FDA 510(k) clearance?

PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET received FDA 510(k) clearance on 1988-01-29, under 510(k) number K874927.

Who is the listed applicant for PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET?

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

What is the FDA product code for PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET?

The FDA product code for PTI HEART-CHILL(TM) CARDIAC INSULATING JACKET is DWC.

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Related Devices (Code: DWC)

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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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