Cleared Traditional

K974617 - PERIPHERAL VASCULAR DILATOR

K974617 is an FDA 510(k) clearance for PERIPHERAL VASCULAR DILATOR, manufactured by Endovascular Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K974617 · Endovascular Instruments, Inc. · Cardiovascular device
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Dec 1998
Decision
355d
Days
Class 2
Risk

K974617 is an FDA 510(k) clearance for the PERIPHERAL VASCULAR DILATOR. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Endovascular Instruments, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 1, 1998 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1310 - 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. Elevated predicate reliance profile. 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 Endovascular Instruments, Inc. devices

FDA 510(k) Submission Details - K974617

510(k) Number K974617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1997
Decision Date December 01, 1998
Days to Decision 355 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
230d slower than avg
Panel avg: 125d · This submission: 355d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRE Device Classification - Class 2, Special Controls

Product Code DRE Dilator, Vessel, For Percutaneous Catheterization
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1310
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 - DRE Dilator, Vessel, For Percutaneous Catheterization

All 67
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K974617.
SUPER SHEATH INTRODUCER SHEATH
K052557 · Togo Medikit Co., Ltd. · Jan 2006
MERIT PRELUDE SHEATH INTRODUCER
K050962 · Merit Medical Systems, Inc. · May 2005
MERIT MAK (MINI ACCESS KIT)
K031691 · Merit Medical Systems, Inc. · Sep 2003
URESIL DILATOR WITH RADIOPAQUE MARKER
K980282 · Uresil Corp. · Apr 1998
COAXIAL DILATOR SET
K974640 · Boston Scientific Corp · Mar 1998
EVT EXPANDABLE SHEATH
K970470 · Guidant Cardiac and Vascular Surgery · Jul 1997