Cleared Special

K020890 - SPYGLASS 4 FR ANGIOGRAPHICY CATHETER

K020890 is the FDA 510(k) clearance for SPYGLASS 4 FR ANGIOGRAPHICY CATHETER by St Jude Medical. It is a Class 2 Cardiovascular device (product code DQO) cleared through the Special 510(k) pathway after a 29-day FDA review.

K020890 · St Jude Medical · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2002
Decision
29d
Days
Class 2
Risk

K020890 is an FDA 510(k) clearance for the SPYGLASS 4 FR ANGIOGRAPHICY CATHETER. Classified as Catheter, Intravascular, Diagnostic (product code DQO), Class II - Special Controls.

Submitted by St Jude Medical (Minnetonka, US). The FDA issued a Cleared decision on April 17, 2002 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1200 - 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.

View all St Jude Medical devices

Submission Details

510(k) Number K020890 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2002
Decision Date April 17, 2002
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQO Catheter, Intravascular, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1200
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 - DQO Catheter, Intravascular, Diagnostic

All 294
Devices cleared under the same product code (DQO) and FDA review panel - the closest regulatory comparables to K020890.
RENEGADE STC 18 MICROCATHETER
K023681 · Boston Scientific Corp · Nov 2002
BOSTON SCIENTIFIC IMAGER II 4F SELECTIVE ANGIOGRAPHIC CATHETER
K022621 · Boston Scientific Corp · Sep 2002
GUIDANT BALLOON CATHETER, SEVERAL MODELS
K021283 · Guidant Corp. · May 2002
CORDIS TRAPEASE PERMANENT VENA CAVA FILTER WITH THE VISEASE ANGIOGRAPHIC VESSEL DILATOR
K020316 · Cordis Corp. · Mar 2002
EDWARDS LIFESCIENCES SWAN-GANZ MONITORING CATHETER WITH OLIGON MATERIAL
K014054 · Edwards Lifesciences, LLC · Mar 2002
CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
K003086 · Concentric Medical, Inc. · May 2001