Cleared Traditional

K021455 - RAPIDO GUIDING CATHETER

Also marketed or referenced as:
RAPIDO GUIDING CATHETER, 8F MODEL# 6775, 6777, 6778, 6779, 6780, 6781, 6782,

K021455 is the FDA 510(k) clearance for RAPIDO GUIDING CATHETER by Guidant Corp.. It is a Class 2 Cardiovascular device (product code DQY) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K021455 · Guidant Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2002
Decision
88d
Days
Class 2
Risk

K021455 is an FDA 510(k) clearance for the RAPIDO GUIDING CATHETER, 6F MODEL# 6776. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Guidant Corp. (St Paul, US). The FDA issued a Cleared decision on August 2, 2002 after a review of 88 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. 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 Guidant Corp. devices

Submission Details

510(k) Number K021455 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 06, 2002
Decision Date August 02, 2002
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K021455.
AGILTRAC .035 PERIPHERAL DILATATION CATHETER
K022738 · Guidant Corp. · Sep 2002
7F LAUNCHER GUIDE CATHETER
K022764 · Medtronic Vascular · Aug 2002
BOSTON SCIENTIFIC ULTRA-SOFT SV BALLOON DILATATION CATHETER
K021735 · Boston Scientific Scimed, Inc. · Aug 2002
CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
K021899 · Concentric Medical, Inc. · Jul 2002
EQUALIZER BALLOON CATHETER
K021721 · Boston Scientific Corp · Jun 2002
MODIFICATION TO ENVOY AND VISTA BRITE TIP
K021593 · Cordis Corp. · Jun 2002