Cleared Traditional

K950440 - DUAL FUNCTION PACING WEDGE PRESSURE BALLOON CATHETER BY J-LLOYD

K950440 is an FDA 510(k) clearance for DUAL FUNCTION PACING WEDGE PRESSURE BAL..., 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 231-day FDA review.

K950440 · J-Lloyd Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1995
Decision
231d
Days
Class 2
Risk

K950440 is an FDA 510(k) clearance for the DUAL FUNCTION PACING 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 September 15, 1995 after a review of 231 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 - K950440

510(k) Number K950440 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1995
Decision Date September 15, 1995
Days to Decision 231 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
106d slower than avg
Panel avg: 125d · This submission: 231d
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 K950440.
ANGIOPTIC ANGIOGRAPHIC CATHETER
K954423 · AngioDynamics, Inc. · Dec 1995
MIKRO-TIP ANGIOGRAPHIC CATHETER
K952773 · Millar Instruments, Inc. · Nov 1995
CATHETER, BALLOON TYPE
K950398 · Interventional Therapeutics Corp. · Oct 1995
EVOLUTION MICROCATHETER
K953114 · Boston Scientific Corp · Sep 1995
BRAUN SELECTIVE ANGIOGRAPHIC CATHETER
K950882 · B.Braun Medical, Inc. · Aug 1995
TRANSIT-2 INFUSION CATHETER
K950910 · Cordis Neurovascular, Inc. · Aug 1995