Cleared Traditional

K971504 - HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER

K971504 is an FDA 510(k) clearance for HEXAPOLAR ELECTRODE BALLOON FLOTATION C..., manufactured by J-Lloyd Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 360-day FDA review.

K971504 · J-Lloyd Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1998
Decision
360d
Days
Class 2
Risk

K971504 is an FDA 510(k) clearance for the HEXAPOLAR ELECTRODE BALLOON FLOTATION CATHETER. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by J-Lloyd Medical, Inc. (West Berlin, US). The FDA issued a Cleared decision on April 20, 1998 after a review of 360 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1220 - 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. Elevated predicate reliance profile. 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 - K971504

510(k) Number K971504 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 25, 1997
Decision Date April 20, 1998
Days to Decision 360 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
235d slower than avg
Panel avg: 125d · This submission: 360d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRF Device Classification - Class 2, Special Controls

Product Code DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1220
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 - DRF Catheter, Electrode Recording, Or Probe, Electrode Recording

All 102
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K971504.
BIOSENSE WEBSTER LASSO DEFLECTABLE CIRCULAR MAPPING CATHETER, MODEL D-1220
K002333 · Biosense Webster, Inc. · Aug 2000
CORDIS 13F CATHETER SHEATH INTRODUCER
K000753 · Cordis Corp. · Apr 2000
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · C.R. Bard, Inc. · Nov 1999
ELECTRODE SEMI-FLOTATION CATHETER BY J-LLOYD MEDICAL, INC.
K973639 · J-Lloyd Medical, Inc. · Apr 1998
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · C.R. Bard, Inc. · Oct 1997
ELECTRODE RECORDING CATHETER
K954651 · Boston Scientific Corp · Oct 1996