Cleared Traditional

K960917 - PERCUGLIDE

K960917 is an FDA 510(k) clearance for PERCUGLIDE, manufactured by Scientific Device Manufacturer, LLC. The device is a Class 2 Cardiovascular device with product code DRE cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K960917 · Scientific Device Manufacturer, LLC · Cardiovascular device
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Jul 1996
Decision
118d
Days
Class 2
Risk

K960917 is an FDA 510(k) clearance for the PERCUGLIDE. Classified as Dilator, Vessel, For Percutaneous Catheterization (product code DRE), Class II - Special Controls.

Submitted by Scientific Device Manufacturer, LLC (San Rafael, US). The FDA issued a Cleared decision on July 2, 1996 after a review of 118 days - within the typical 510(k) review window.

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 Scientific Device Manufacturer, LLC devices

FDA 510(k) Submission Details - K960917

510(k) Number K960917 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 06, 1996
Decision Date July 02, 1996
Days to Decision 118 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
7d faster than avg
Panel avg: 125d · This submission: 118d
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 74
Devices cleared under the same product code (DRE) and FDA review panel - the closest regulatory comparables to K960917.
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
WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI)
K914555 · Med Institute, Inc. · Jan 1992
VESSEL DILATOR
K913027 · Deseret Medical, Inc. · Nov 1991
VESSEL DILATOR
K904476 · Datascope Corp. · Dec 1990