Cleared Traditional

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

K891786 is an FDA 510(k) clearance for PTI INTRA-ART CORONARY ARTERY PROBE (ST..., manufactured by Pioneering Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DWP cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K891786 · Pioneering Technologies, Inc. · Cardiovascular device
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Oct 1989
Decision
202d
Days
Class 2
Risk

K891786 is an FDA 510(k) clearance for the PTI INTRA-ART(R) CORONARY ARTERY PROBE (STERILE). Classified as Dilator, Vessel, Surgical (product code DWP), Class II - Special Controls.

Submitted by Pioneering Technologies, Inc. (Wheat Ridge, US). The FDA issued a Cleared decision on October 12, 1989 after a review of 202 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4475 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Pioneering Technologies, Inc. devices

FDA 510(k) Submission Details - K891786

510(k) Number K891786 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 24, 1989
Decision Date October 12, 1989
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWP Device Classification - Class 2, Special Controls

Product Code DWP Dilator, Vessel, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4475
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DWP Dilator, Vessel, Surgical

All 15
Devices cleared under the same product code (DWP) and FDA review panel - the closest regulatory comparables to K891786.
ROBICSEK PROBE/RETRACTOR
K910682 · Bio-Vascular, Inc. · May 1991
FLO-RESTER(R) VESSEL SIZER
K905159 · Bio-Vascular, Inc. · Feb 1991
FOGARTY VESSEL CALIBRATOR
K902143 · Baxter Healthcare Corp · Oct 1990
VESSEL DILATOR
K832595 · Abbott Laboratories · Aug 1983
REUSABLE FOGARTY FLEXIBLE CALIBRATOR
K822687 · American Edwards Laboratories · Oct 1982
FOGARTY FLEXIBLE PROBE
K812935 · American Edwards Laboratories · Nov 1981