Cleared Traditional

K964547 - DEGANIA SILICONE INDENTI LOOPS

K964547 is an FDA 510(k) clearance for DEGANIA SILICONE INDENTI LOOPS, manufactured by Degania Silicone , Ltd.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K964547 · Degania Silicone , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1997
Decision
56d
Days
Class 2
Risk

K964547 is an FDA 510(k) clearance for the DEGANIA SILICONE INDENTI LOOPS. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Degania Silicone , Ltd. (Emek Hayarden, IL). The FDA issued a Cleared decision on January 8, 1997 after a review of 56 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Degania Silicone , Ltd. devices

FDA 510(k) Submission Details - K964547

510(k) Number K964547 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 1996
Decision Date January 08, 1997
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DXC Device Classification - Class 2, Special Controls

Product Code DXC Clamp, Vascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - DXC Clamp, Vascular

All 163
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K964547.
CTS MIDCAB CORONARY SHUNT
K963503 · Cardiothoracic Systems, Inc. · Apr 1997
MICS DEVICE SYSTEM
K963716 · Percutaneous Technologies, Inc. · Apr 1997
FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15
K964662 · Rmds, Inc. · Feb 1997
HEARTPORT CABLE BULLDOG CLAMP
K962366 · Heartport, Inc. · Nov 1996
AMR-ACV CLAMPS
K962668 · Applied Medical Resources · Nov 1996
DANESHVAR WOUND SUPPORT UNIT
K955827 · Y. Daneshvar · Oct 1996