Cleared Traditional

K981956 - DEGANIA SILICONE IDENTI LOOPS

K981956 is the FDA 510(k) clearance for DEGANIA SILICONE IDENTI LOOPS by Degania Silicone , Ltd.. It is a Class 2 Cardiovascular device (product code DXC) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K981956 · Degania Silicone , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
35d
Days
Class 2
Risk

K981956 is an FDA 510(k) clearance for the DEGANIA SILICONE IDENTI 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 July 9, 1998 after a review of 35 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

Submission Details

510(k) Number K981956 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1998
Decision Date July 09, 1998
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 63
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K981956.
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K984214 · Cordis Neurovascular, Inc. · Aug 1999
FLEXIBLE VASCULAR CLAMP, VERSION 2
K991589 · Allegiance Healthcare Corp. · May 1999
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998
SURGICAL VASCULAR CLAMP
K973080 · Walter Lorenz Surgical, Inc. · Feb 1998
ORIGIN CARDIAC STABLIZER OCCLUDER
K970611 · Origin Medsystems, Inc. · Aug 1997