Cleared Traditional

K981359 - GT LEGGIERO

K981359 is an FDA 510(k) clearance for GT LEGGIERO, manufactured by Terumo Medical Corp.. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 288-day FDA review.

K981359 · Terumo Medical Corp. · Cardiovascular device
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K981359

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.

DQY Device Classification - Class 2, Special Controls

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 621
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K981359.
SPECTRANETICS 0.014 SUPPORT CATHETER, MODEL 518-016, SPECTRANETICS 0.018 SUPPORT CATHETER, MODEL 518-017
K991059 · Spectranetics Corp. · Nov 1999
VISTA BRITE TIP CATHETERS
K992673 · Cordis Corp. · Oct 1999
ENVY GUIDING CATHETER
K990726 · Cook, Inc. · Apr 1999
URESIL VASCU-FLO INFUSION CATHETER
K980278 · Uresil Corp. · Nov 1998
ENVOY AND VISTA BRITE TIP
K982632 · Cordis Corp. · Aug 1998
6F ENVOY GUIDING CATHETER
K982770 · Cordis Corp. · Aug 1998