Cleared Special

K991589 - FLEXIBLE VASCULAR CLAMP

K991589 is an FDA 510(k) clearance for FLEXIBLE VASCULAR CLAMP, manufactured by Allegiance Healthcare Corp.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Special 510(k) pathway after a 11-day FDA review.

K991589 · Allegiance Healthcare Corp. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1999
Decision
11d
Days
Class 2
Risk

K991589 is an FDA 510(k) clearance for the FLEXIBLE VASCULAR CLAMP, VERSION 2. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on May 18, 1999 after a review of 11 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K991589

510(k) Number K991589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 1999
Decision Date May 18, 1999
Days to Decision 11 days
Submission Type Special
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
114d faster than avg
Panel avg: 125d · This submission: 11d
Pathway characteristics
Modification to existing cleared device.

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 84
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K991589.
MALLEABLE SHAFT CLAMP
K011078 · Allegiance Healthcare Corp. · Jul 2001
AESCULAP VASCULAR INSTRUMENTS
K992053 · Aesculap, Inc. · Jan 2000
CORDIS ENDOVASCULAR TEMPORARY OCCLUSION BALLOON CATHETER
K984214 · Cordis Neurovascular, Inc. · Aug 1999
FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER
K983471 · Radi Medical Systems AB · Feb 1999
FEMOSTOP II PLUS DISPOSABLE SET MODEL 11166, FEMOSTOP II PLUS COMPRESSION ARCH MODEL 11168, FEMOSTOP II BILATERAL ADAPT0
K982182 · Radi Medical Systems AB · Sep 1998
FLO-THRU
K981624 · Bio-Vascular, Inc. · Aug 1998