Cleared Traditional

GT LEGGIERO (K981359) - FDA 510(k) Clearance

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

K981359 · Terumo Medical Corp. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jan 1999
Decision
288d
Days
Class 2
Risk

K981359 is an FDA 510(k) clearance for the GT LEGGIERO. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Terumo Medical Corp. (Elkton, US). The FDA issued a Cleared decision on January 27, 1999 after a review of 288 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 Terumo Medical Corp. devices

Submission Details

510(k) Number K981359 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1998
Decision Date January 27, 1999
Days to Decision 288 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
163d slower than avg
Panel avg: 125d · This submission: 288d
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 344
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K981359.
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K990726 · Cook, Inc. · Apr 1999
ENVOY AND VISTA BRITE TIP
K982632 · Cordis Corp. · Aug 1998
6F ENVOY GUIDING CATHETER
K982770 · Cordis Corp. · Aug 1998
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
K974684 · Scimed Life Systems, Inc. · Feb 1998