Cleared Traditional

K935405 - ARTERIAL EMBOLECTOMY

K935405 is an FDA 510(k) clearance for ARTERIAL EMBOLECTOMY, manufactured by J-Lloyd Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DXE cleared through the Traditional 510(k) pathway after a 258-day FDA review.

K935405 · J-Lloyd Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
258d
Days
Class 2
Risk

K935405 is an FDA 510(k) clearance for the ARTERIAL EMBOLECTOMY. Classified as Catheter, Embolectomy (product code DXE), Class II - Special Controls.

Submitted by J-Lloyd Medical, Inc. (West Berlin, US). The FDA issued a Cleared decision on July 25, 1994 after a review of 258 days - an extended review 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: 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 J-Lloyd Medical, Inc. devices

FDA 510(k) Submission Details - K935405

510(k) Number K935405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date July 25, 1994
Days to Decision 258 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
133d slower than avg
Panel avg: 125d · This submission: 258d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXE Device Classification - Class 2, Special Controls

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 44
Devices cleared under the same product code (DXE) and FDA review panel - the closest regulatory comparables to K935405.
DUAL LUMEN EMBOLECTOMY CATHETER
K970762 · Applied Medical Resources · Mar 1997
NEEDLE'S EYE SNARE
K961992 · Cook Pacemaker Corp. · Dec 1996
AVD INTIMAX THROMBECTOMY CATHETER
K950586 · Applied Medical Resources · May 1995
WELTER SNARE RETRIEVER
K920823 · Cook, Inc. · Mar 1993
INTIMAX THROMBECTOMY CATHETER
K910372 · Applied Vascular Devices, Inc. · Apr 1991
AMPLATZ GOOSE-NECK SNARE
K901502 · Microvena Corp. · Dec 1990