PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE— 510(k) K901531

Name: FDA 510(k) clearance K901531
Creator: U.S. Food and Drug Administration
Published: 1990-06-20

Substantially Equivalent

Pioneering Technologies, Inc.

FDA 510(k) clearance K901531 for PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE, Substantially Equivalent on 1990-06-20. Applicant: Pioneering Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Pioneering Technologies, Inc.
Product code: Code DNP
Device class: Class 2
Regulation: 21 CFR 862.3380
Advisory panel: Clinical Toxicology
Date received: 1990-03-22
Decision date: 1990-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheat Ridge, CO, US

Download summary PDF View on FDA.gov ↗

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