Cleared Traditional

K951744 - LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIO...

K951744 is the FDA 510(k) clearance for LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIO... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K951744 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1995
Decision
35d
Days
Class 2
Risk

K951744 is an FDA 510(k) clearance for the LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on May 4, 1995 after a review of 35 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K951744 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1995
Decision Date May 04, 1995
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 96
Devices cleared under the same product code (DRF) and FDA review panel - the closest regulatory comparables to K951744.
CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
K953750 · Boston Scientific Corp · Mar 1996
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM
K953651 · Arrow Intl., Inc. · Nov 1995
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS
K945229 · Arrow Intl., Inc. · Aug 1995
CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION
K933450 · Electro-Catheter Corp. · Apr 1995
OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION
K933451 · Electro-Catheter Corp. · Apr 1995
TIP DEFLECTOR (GENESIS)
K943257 · Electro-Catheter Corp. · Apr 1995