Cleared Traditional

K970470 - EVT EXPANDABLE SHEATH

K970470 is an FDA 510(k) clearance for EVT EXPANDABLE SHEATH, manufactured by Guidant Cardiac and Vascular Surgery. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 174-day FDA review.

K970470 · Guidant Cardiac and Vascular Surgery · Cardiovascular device
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Jul 1997
Decision
174d
Days
Class 2
Risk

K970470 is an FDA 510(k) clearance for the EVT EXPANDABLE SHEATH. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Guidant Cardiac and Vascular Surgery (Menlo Park, US). The FDA issued a Cleared decision on July 31, 1997 after a review of 174 days - an extended review cycle.

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. 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 Guidant Cardiac and Vascular Surgery devices

FDA 510(k) Submission Details - K970470

510(k) Number K970470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 07, 1997
Decision Date July 31, 1997
Days to Decision 174 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
49d slower than avg
Panel avg: 125d · This submission: 174d
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 K970470.
PERIPHERAL VASCULAR DILATOR
K974617 · Endovascular Instruments, Inc. · Dec 1998
URESIL DILATOR WITH RADIOPAQUE MARKER
K980282 · Uresil Corp. · Apr 1998
COAXIAL DILATOR SET
K974640 · Boston Scientific Corp · Mar 1998
CORDIS AVANTI+CATHETER SHEATH INTRODUCER SYSTEM
K970392 · Cordis Corp. · Apr 1997
FLEXIBLE DILATING SHEATH
K945586 · Med Institute, Inc. · Apr 1997
VESSEL DILATOR
K963388 · Maxxim Medical · Mar 1997