510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901531Substantially Equivalent

Pti Intra-Artr Reusable Coronary Artery Probe

Pioneering Technologies, Inc., Wheat Ridge CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901531 is the FDA 510(k) clearance record for PTI INTRA-ARTR REUSABLE CORONARY ARTERY PROBE, a class II device, cleared for Pioneering Technologies, Inc. on under FDA product code DNP (Thin Layer Chromatography, Ethosuximide). FDA records list 19 510(k) clearances for Pioneering Technologies, Inc., from to . As of , FDA records show no recalls naming K901531.

Clearance record

Decision date
Received
(90 days to decision)
Product code
DNP Thin Layer Chromatography, Ethosuximide
Regulation
21 CFR 862.3380
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Pioneering Technologies, Inc. 3900 Youngfield St., Wheat Ridge CO
Third party review
No

Clearances, product code DNP

Trailing 12 months

FDA records hold no clearances under product code DNP in the trailing twelve months.

FDA records show no clearances under product code DNP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DNP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260