Cleared Traditional

AVE GL-1 GUIDING CATHETER (K984482) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K984482 · Arterial Vascular Engineering Massachusetts, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1999
Decision
226d
Days
Class 2
Risk

K984482 is an FDA 510(k) clearance for the AVE GL-1 GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Arterial Vascular Engineering Massachusetts, Inc. (Billerica, US). The FDA issued a Cleared decision on July 30, 1999 after a review of 226 days - an extended review 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: 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 Arterial Vascular Engineering Massachusetts, Inc. devices

Submission Details

510(k) Number K984482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 1998
Decision Date July 30, 1999
Days to Decision 226 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
101d slower than avg
Panel avg: 125d · This submission: 226d
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 304
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K984482.
ENVOY AND VISTA BRITE TIP
K000715 · Cordis Corp. · Mar 2000
ZUMA GUIDE CATHETERS
K000677 · Medtronic Vascular · Mar 2000
VISTA BRITE TIP CATHETERS
K992673 · Cordis Corp. · Oct 1999
ENVY GUIDING CATHETER
K990726 · Cook, Inc. · Apr 1999
ENVOY AND VISTA BRITE TIP
K982632 · Cordis Corp. · Aug 1998
6F ENVOY GUIDING CATHETER
K982770 · Cordis Corp. · Aug 1998