Cleared Traditional

K980578 - INNERDYNE RADIALLY EXPANDING VASCULAR A...

K980578 is an FDA 510(k) clearance for INNERDYNE RADIALLY EXPANDING VASCULAR A..., manufactured by Innerdyne, Inc.. The device is a Class 2 Cardiovascular device with product code DYB cleared through the Traditional 510(k) pathway after a 206-day FDA review.

K980578 · Innerdyne, Inc. · Cardiovascular device
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Sep 1998
Decision
206d
Days
Class 2
Risk

K980578 is an FDA 510(k) clearance for the INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM (HEPARIN COATED). Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Innerdyne, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 11, 1998 after a review of 206 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - 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 Innerdyne, Inc. devices

FDA 510(k) Submission Details - K980578

510(k) Number K980578 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1998
Decision Date September 11, 1998
Days to Decision 206 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
81d slower than avg
Panel avg: 125d · This submission: 206d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DYB Device Classification - Class 2, Special Controls

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 - DYB Introducer, Catheter

All 410
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K980578.
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K984500 · Cordis Corp. · Dec 1998
MODIFICATION TO CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K983023 · Cordis Corp. · Oct 1998
FAST-CATH INTRA-CARDIAC INTRODUCER
K982187 · Daig Corp. · Sep 1998
LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM
K981782 · Arrow Intl., Inc. · Aug 1998
FAST-CATH (TM) INTRA-CARDIAC INTRODUCER
K973840 · Daig Corp. · May 1998
ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET
K970229 · Arrow Intl., Inc. · Feb 1998