510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K891786Substantially Equivalent

Pti Intra-Art(r) Coronary Artery Probe (Sterile)

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

K891786 is the FDA 510(k) clearance record for PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE), a class II device, cleared for Pioneering Technologies, Inc. on under FDA product code DWP (Dilator, Vessel, Surgical). FDA records list 19 510(k) clearances for Pioneering Technologies, Inc., from to . As of , FDA records show no recalls naming K891786.

Clearance record

Decision date
Received
(202 days to decision)
Product code
DWP Dilator, Vessel, Surgical
Regulation
21 CFR 870.4475
Device class
Class II
Review panel
Cardiovascular
Applicant
Pioneering Technologies, Inc. 3900 Youngfield St., Wheat Ridge CO
Third party review
No

Clearances, product code DWP

Trailing 12 months

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

FDA records show no clearances under product code DWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DWP, 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