Cleared Traditional

K911065 - ARROW QUADPOLAR MAPPING/PACING CATHETER

K911065 is an FDA 510(k) clearance for ARROW QUADPOLAR MAPPING/PACING CATHETER, 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 463-day FDA review.

K911065 · Arrow Intl., Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1992
Decision
463d
Days
Class 2
Risk

K911065 is an FDA 510(k) clearance for the ARROW QUADPOLAR MAPPING/PACING CATHETER. 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 June 18, 1992 after a review of 463 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Arrow Intl., Inc. devices

FDA 510(k) Submission Details - K911065

510(k) Number K911065 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1991
Decision Date June 18, 1992
Days to Decision 463 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
338d slower than avg
Panel avg: 125d · This submission: 463d
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 K911065.
TIP DEFLECTOR (GENESIS)
K943257 · Electro-Catheter Corp. · Apr 1995
DAIG DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER
K942379 · Daig Corp. · Dec 1994
EXPLORER/360-POLARIS-L.E./JACKMAN CORON SINUS ELEC
K924163 · Boston Scientific Corp · Sep 1993
DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN
K914278 · Daig Corp. · Mar 1992
MEDTRONIC MODEL 5407S, 5807S & 5410S SURG CABLES
K914460 · Medtronic Vascular · Nov 1991
BARD(R) ENDOCARDIAL BALLOON ARRAY
K911140 · C.R. Bard, Inc. · May 1991