Cleared Traditional

K972684 - INNERDYNE RADIALLY EXPANDING VASCULAR A...

K972684 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 85-day FDA review.

K972684 · Innerdyne, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1997
Decision
85d
Days
Class 2
Risk

K972684 is an FDA 510(k) clearance for the INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM. 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 October 10, 1997 after a review of 85 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innerdyne, Inc. devices

FDA 510(k) Submission Details - K972684

510(k) Number K972684 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 1997
Decision Date October 10, 1997
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 K972684.
ARROW TRANSSEPTAL SUPER ARROW-FLEX PERCUTANEOUS SET
K970229 · Arrow Intl., Inc. · Feb 1998
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K974448 · Cordis Corp. · Feb 1998
DATASCOPE'S 10 FR. FLEXISHEATH PERCUTANEOUS INTRODUCER
K973007 · Datascope Corp. · Nov 1997
CORDIS BRITE TIP CATHETER SHEATH INTRODUCER SYSTEM
K971608 · Cordis Corp. · Jul 1997
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER
K964518 · Daig Corp. · May 1997
TRANSJUGULAR ACCESS SET
K964034 · AngioDynamics, Inc. · May 1997