Cleared Traditional

K935403 - WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD

K935403 is an FDA 510(k) clearance for WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD, manufactured by J-Lloyd Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DQO cleared through the Traditional 510(k) pathway after a 184-day FDA review.

K935403 · J-Lloyd Medical, Inc. · Cardiovascular device
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May 1994
Decision
184d
Days
Class 2
Risk

K935403 is an FDA 510(k) clearance for the WEDGE PRESSURE 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 May 12, 1994 after a review of 184 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

FDA 510(k) Submission Details - K935403

510(k) Number K935403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1993
Decision Date May 12, 1994
Days to Decision 184 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQO Device Classification - Class 2, Special Controls

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 366
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K935403.
DYE MANAGEMENT SYSTEM
K941254 · Abbott Laboratories · Jun 1994
TRANSIT INFUSION CATHETER
K936260 · Cordis Corp. · May 1994
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION
K934541 · Scimed Life Systems, Inc. · May 1994
ANGIOGRAPHIC BALLOON CATHETER BY J-LLOYD
K935402 · J-Lloyd Medical, Inc. · Apr 1994
SCIMED 5, 7, AND 8 FRENCH ANGIOGRAPHIC CATHETERS
K934581 · Scimed Life Systems, Inc. · Mar 1994
DIAGNOSTIC INTRAVASCULAR CATHETER
K925813 · Target Therapeutics · Mar 1994