Cleared Traditional

ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD (K935402) - FDA 510(k) Clearance

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

K935402 · J-Lloyd Medical, Inc. · Cardiovascular device
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Apr 1994
Decision
168d
Days
Class 2
Risk

K935402 is an FDA 510(k) clearance for the ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by J-Lloyd Medical, Inc. (West Berlin, US). The FDA issued a Cleared decision on April 26, 1994 after a review of 168 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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

Submission Details

510(k) Number K935402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date April 26, 1994
Days to Decision 168 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
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 145
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K935402.
HAND CONTROLLED SYRINGE
K942329 · Abbott Laboratories · Jun 1994
DYE MANAGEMENT SYSTEM
K941254 · Abbott Laboratories · Jun 1994
TRANSIT INFUSION CATHETER
K936260 · Cordis Corp. · May 1994
DYE MANAGEMENT SYSTEM
K933700 · Abbott Laboratories · Nov 1993
USCI ANGIOGRAPHIC CATHETER
K932092 · C.R. Bard, Inc. · Jul 1993
CORDIS 7 FRENCH THRULUMEN CATHETER
K922891 · Cordis Corp. · Jun 1993