Cleared Traditional

EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER (K864007) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K864007 · Uresil Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1987
Decision
79d
Days
Class 2
Risk

K864007 is an FDA 510(k) clearance for the EMBOLECTOMY/THROMBECTOMY BALLOON CATHETER. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by Uresil Corp. (Skokie, US). The FDA issued a Cleared decision on January 2, 1987 after a review of 79 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5150 - 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 Uresil Corp. devices

Submission Details

510(k) Number K864007 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1986
Decision Date January 02, 1987
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
46d faster than avg
Panel avg: 125d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXE Catheter, Embolectomy
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5150
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 - DXE Catheter, Embolectomy

All 20
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K864007.
FOGARTY ARTERIAL EMBOLECTOMY II CATHETER
K901625 · Baxter Healthcare Corp · Jul 1990
REVISED LABELING FOR ARTERIAL EMBOLECTOMY CATHETER
K894681 · Shiley, Inc. · Oct 1989
FOGARTY(R) THRU-LUMEN EMBOLECTOMY CATHETER
K892410 · Baxter Healthcare Corp · Jul 1989
ARTERIAL EMBOLECTOMY CATHETER
K840198 · Shiley, Inc. · Aug 1984
SHILEY MULTIPRO CATHETER
K832044 · Shiley, Inc. · Sep 1983
ARTERIAL EMBOLECTOMY CATHETER (MODIFIED)
K790838 · Shiley, Inc. · Jun 1979