Cleared Special

K011766 - 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722

Also marketed or referenced as:
6F EAVUATOR ELECTROPHYSISOLOGY CATHETER, JSN #402721, 4027

K011766 is an FDA 510(k) clearance for 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, manufactured by St Jude Medical. The device is a Class 2 Cardiovascular device with product code DRF cleared through the Special 510(k) pathway after a 26-day FDA review.

K011766 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2001
Decision
26d
Days
Class 2
Risk

K011766 is an FDA 510(k) clearance for the 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722. Classified as Catheter, Electrode Recording, Or Probe, Electrode Recording (product code DRF), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on July 3, 2001 after a review of 26 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K011766

510(k) Number K011766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 07, 2001
Decision Date July 03, 2001
Days to Decision 26 days
Submission Type Special
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
99d faster than avg
Panel avg: 125d · This submission: 26d
Pathway characteristics
Modification to existing cleared device.

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 185
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K011766 · 6F EVALUATOR ELECTROPHYSIOLOGY CATHETER, CRD # 402720,402722
Download PDF FDA Summary St Jude Medical