PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE)— 510(k) K883135

Name: FDA 510(k) clearance K883135
Creator: U.S. Food and Drug Administration
Published: 1988-09-26

Substantially Equivalent

Pioneering Technologies, Inc.

FDA 510(k) clearance K883135 for PTI HEART-LIFT(TM) CARDIAC ELEVATOR (STERILE), Substantially Equivalent on 1988-09-26. Applicant: Pioneering Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Pioneering Technologies, Inc.
Product code: Code DWS
Device class: Class 1
Regulation: 21 CFR 870.4500
Advisory panel: Cardiovascular
Date received: 1988-07-26
Decision date: 1988-09-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.