Cleared Special

K000598 - 5F GUIDING CATHETER

K000598 is the FDA 510(k) clearance for 5F GUIDING CATHETER by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Special 510(k) pathway after a 30-day FDA review.

K000598 · Guidant Corp. · Cardiovascular device
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Mar 2000
Decision
30d
Days
Class 2
Risk

K000598 is an FDA 510(k) clearance for the 5F GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Guidant Corp. (Santa Clara, US). The FDA issued a Cleared decision on March 24, 2000 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - 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 Guidant Corp. devices

Submission Details

510(k) Number K000598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2000
Decision Date March 24, 2000
Days to Decision 30 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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
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 - DQY Catheter, Percutaneous

All 588
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K000598.
CORDIS INTRODUCER GUIDE
K001136 · Cordis Corp. · Apr 2000
ENVOY AND VISTA BRITE TIP
K000715 · Cordis Corp. · Mar 2000
ZUMA GUIDE CATHETERS
K000677 · Medtronic Vascular · Mar 2000
VERIPATH PERIPHERAL GUIDING CATHETER
K994229 · Advanced Cardiovascular Systems, Inc. · Feb 2000
VISTA BRITE TIP CATHETERS
K992673 · Cordis Corp. · Oct 1999
ENVY GUIDING CATHETER
K990726 · Cook, Inc. · Apr 1999