Cleared Traditional

K953651 - DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER S...

K953651 is an FDA 510(k) clearance for DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER S..., manufactured by Arrow Intl., Inc.. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K953651 · Arrow Intl., Inc. · Cardiovascular device
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Nov 1995
Decision
118d
Days
Class 2
Risk

K953651 is an FDA 510(k) clearance for the DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Arrow Intl., Inc. (Reading, US). The FDA issued a Cleared decision on November 30, 1995 after a review of 118 days - within the typical 510(k) review window.

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. 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 Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K953651

510(k) Number K953651 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1995
Decision Date November 30, 1995
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
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 98
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K953651.
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · C.R. Bard, Inc. · Oct 1997
ELECTRODE RECORDING CATHETER
K954651 · Boston Scientific Corp · Oct 1996
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · Boston Scientific Corp · Mar 1996
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS
K945229 · Arrow Intl., Inc. · Aug 1995
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
K951744 · Boston Scientific Corp · May 1995
CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION
K933450 · Electro-Catheter Corp. · Apr 1995