Cleared Traditional

K981198 - MEDTRONIC ZUMA GUIDING CATHETER

K981198 is an FDA 510(k) clearance for MEDTRONIC ZUMA GUIDING CATHETER, manufactured by Medtronics Interventional Vascular. The device is a Class 2 Cardiovascular device with product code DQY cleared through the Traditional 510(k) pathway after a 127-day FDA review.

K981198 · Medtronics Interventional Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Aug 1998
Decision
127d
Days
Class 2
Risk

K981198 is an FDA 510(k) clearance for the MEDTRONIC ZUMA GUIDING CATHETER. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by Medtronics Interventional Vascular (Danvers, US). The FDA issued a Cleared decision on August 7, 1998 after a review of 127 days - within the typical 510(k) review window.

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 Medtronics Interventional Vascular devices

FDA 510(k) Submission Details - K981198

510(k) Number K981198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1998
Decision Date August 07, 1998
Days to Decision 127 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
2d slower than avg
Panel avg: 125d · This submission: 127d
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 648
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K981198.
ENVOY AND VISTA BRITE TIP
K982632 · Cordis Corp. · Aug 1998
6F ENVOY GUIDING CATHETER
K982770 · Cordis Corp. · Aug 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K980453 · Boston Scientific Scimed, Inc. · Aug 1998
SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS
K981413 · Boston Scientific Scimed, Inc. · May 1998
SCIMED 7 FRENCH WISEGUIDE GUIDE CATHETER
K974684 · Scimed Life Systems, Inc. · Feb 1998
CERTODYN RAECG UNIVERSAL ADAPTER
K973371 · B.Braun Medical, Inc. · Nov 1997