Cleared Special

K110193 - FEMOSTOP PLYS

Also marketed or referenced as:
FEMOSTOP II PLUS SET FEMOSTOP II PLUS ARCH, BILATERAL ADAPTER F

K110193 is an FDA 510(k) clearance for FEMOSTOP PLYS, manufactured by St. Jude Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Special 510(k) pathway after a 31-day FDA review.

K110193 · St. Jude Medical Systems AB · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
31d
Days
Class 2
Risk

K110193 is an FDA 510(k) clearance for the FEMOSTOP PLYS, FEMOSTOP HD, FEMOSTOP COMPRESSION ARCH. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by St. Jude Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on February 24, 2011 after a review of 31 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 St. Jude Medical Systems AB devices

FDA 510(k) Submission Details - K110193

510(k) Number K110193 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2011
Decision Date February 24, 2011
Days to Decision 31 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
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 94
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K110193.
MICROFRANCE(R) WORMALD VASCULAR CLAMP
K112662 · Medtronic Xomed, Inc. · Jan 2012
EDWARDS LIFESCIENCES INTRACLUDE INTRA-AORTIC CATHETER
K113182 · Edwards Lifesciences, LLC · Dec 2011
EDWARDS LIFESCIENCES ENDOCLAMP AORTIC CATHETER
K112694 · Edwards Lifesciences, LLC · Oct 2011
MODIFICATION TO FEMOSTOP FEMORAL COMPRESSION SYSTEM
K080206 · Radi Medical Systems AB · Feb 2008
TR BAND
K070423 · Terumo Medical Corp. · Mar 2007
D-STAT HANDLE, MODEL 8500-053
K063871 · Vascular Solutions, Inc. · Feb 2007