PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE)— 510(k) K891786

Name: FDA 510(k) clearance K891786
Creator: U.S. Food and Drug Administration
Published: 1989-10-12

Substantially Equivalent

Pioneering Technologies, Inc.

FDA 510(k) clearance K891786 for PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE), Substantially Equivalent on 1989-10-12. Applicant: Pioneering Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Pioneering Technologies, Inc.
Product code: Code DWP
Device class: Class 2
Regulation: 21 CFR 870.4475
Advisory panel: Cardiovascular
Date received: 1989-03-24
Decision date: 1989-10-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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