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FDA 510(k)

PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI

K-Number: K882381 · 1988-07-07

ApplicantPioneering Technologies, Inc.
Decision Date1988-07-07
Product CodeKGO
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI 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 1988-07-07 under 510(k) number K882381. The device is classified under product code KGO. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI?

PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI is a medical device that received FDA 510(k) clearance on 1988-07-07. The listed applicant is Pioneering Technologies, Inc.. The 510(k) number is K882381.

When did PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI receive FDA 510(k) clearance?

PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI received FDA 510(k) clearance on 1988-07-07, under 510(k) number K882381.

Who is the listed applicant for PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI?

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-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI?

The FDA product code for PTI HEART-LIFT(TM) CARDIAC RETRACTION GLOVES-STERI is KGO.

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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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