Cleared Traditional

K953750 - CATHETER

K953750 is the FDA 510(k) clearance for CATHETER by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DRF) cleared through the Traditional 510(k) pathway after a 214-day FDA review.

K953750 · Boston Scientific Corp · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
214d
Days
Class 2
Risk

K953750 is an FDA 510(k) clearance for the CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING. 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 March 11, 1996 after a review of 214 days - an extended review 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: 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 Boston Scientific Corp devices

Submission Details

510(k) Number K953750 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1995
Decision Date March 11, 1996
Days to Decision 214 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
89d slower than avg
Panel avg: 125d · This submission: 214d
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 K953750.
ORBITER ST DIAGNOSTIC ELECTRODE CATHETER & ORBITER ST EXTENSION CABLE
K992373 · C.R. Bard, Inc. · Nov 1999
VIKING DIAGNOSTIC ELECTRODE CATHETER
K971265 · C.R. Bard, Inc. · Oct 1997
ELECTRODE RECORDING CATHETER
K954651 · Boston Scientific Corp · Oct 1996
DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER SYSTEM
K953651 · Arrow Intl., Inc. · Nov 1995
ARROW MULTIPOLAR INTRACARDIAC ELECTRODE CATHETERS
K945229 · Arrow Intl., Inc. · Aug 1995
LARGE TIP (4MM) DIAGNOSTIC-ELECTROHYSIOLOGY CATHETERS
K951744 · Boston Scientific Corp · May 1995