Cleared Traditional

K882879 - PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER)

K882879 is an FDA 510(k) clearance for PTI INTRA-ART(TM) CORONARY ARTERY OCCLU..., manufactured by Pioneering Technologies, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K882879 · Pioneering Technologies, Inc. · Cardiovascular device
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Sep 1988
Decision
63d
Days
Class 2
Risk

K882879 is an FDA 510(k) clearance for the PTI INTRA-ART(TM) CORONARY ARTERY OCCLUDERS (STER). Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Pioneering Technologies, Inc. (Lakewood, US). The FDA issued a Cleared decision on September 12, 1988 after a review of 63 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Pioneering Technologies, Inc. devices

FDA 510(k) Submission Details - K882879

510(k) Number K882879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 11, 1988
Decision Date September 12, 1988
Days to Decision 63 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
62d faster than avg
Panel avg: 125d · This submission: 63d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 155
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K882879.
ATRAUMAX(TM) SURGICAL CLAMPS
K891296 · Applied Vascular Devices, Inc. · Jun 1989
SURGICAL CLAMP INSERTS
K883790 · Applied Vascular Devices, Inc. · Dec 1988
FLO-RESTER
K883696 · Bio-Vascular, Inc. · Nov 1988
VASCULAR CLAMP
K881158 · T. Korossurgical Instruments Corp. · Jun 1988
AUTO SUTURE DISPOSABLE APPROXIMATING CLAMP*
K875090 · United States Surgical, A Division of Tyco Healthc · Feb 1988
MICRO ANASTOMOSIS CLAMP
K861924 · Pilling Co. · Jun 1986