Cleared Traditional

K880860 - CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015

K880860 is an FDA 510(k) clearance for CORONARY OSTIUM OCCLUDER, manufactured by Dlp, Inc.. The device is a Class 2 Cardiovascular device with product code DQT cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K880860 · Dlp, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
86d
Days
Class 2
Risk

K880860 is an FDA 510(k) clearance for the CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015. Classified as Occluder, Catheter Tip (product code DQT), Class II - Special Controls.

Submitted by Dlp, Inc. (Grand Rapids, US). The FDA issued a Cleared decision on May 26, 1988 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1370 - 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.

FDA 510(k) Submission Details - K880860

510(k) Number K880860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1988
Decision Date May 26, 1988
Days to Decision 86 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
39d faster than avg
Panel avg: 125d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQT Device Classification - Class 2, Special Controls

Product Code DQT Occluder, Catheter Tip
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1370
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 - DQT Occluder, Catheter Tip

All 11
Devices cleared under the same product code (DQT) and FDA review panel - the closest regulatory comparables to K880860.
THE OMNIGUIDE GUIDING CATHETER WITH BALLOON
K945963 · Micro Interventional Systems, Inc. · Feb 1995
CATHLAB SILICONE OCCLUSION BALLOON CATHETER
K910916 · Cathlab Corp. · Jun 1991
AVD INTIMAX OCCLUSION CATHETER
K910339 · Applied Vascular Devices, Inc. · May 1991
MODIFIED PRUITT IRRIGATION & OCCLUSION CATHETER
K880231 · Ideas For Medicine, Inc. · May 1988
THE ROBICSEK - PRUITT AORTIC BALLOON OCCLUSION KIT
K872090 · Ideas For Medicine, Inc. · Oct 1987
PERFUSION CATHETER
K872790 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1987
K880860 · CORONARY OSTIUM OCCLUDER, CATALOG CODE 32015
Download PDF Dlp, Inc.