Cleared Traditional

K983471 - FEMOSTOP COMPRESSION ARCH

K983471 is an FDA 510(k) clearance for FEMOSTOP COMPRESSION ARCH, manufactured by Radi Medical Systems AB. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K983471 · Radi Medical Systems AB · Cardiovascular device
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Feb 1999
Decision
144d
Days
Class 2
Risk

K983471 is an FDA 510(k) clearance for the FEMOSTOP COMPRESSION ARCH, FEMOSTOP PUMP, FEMOSTOP BILATERAL ADAPTER. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Radi Medical Systems AB (Uppsala, SE). The FDA issued a Cleared decision on February 23, 1999 after a review of 144 days - within the typical 510(k) review window.

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: 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 Radi Medical Systems AB devices

FDA 510(k) Submission Details - K983471

510(k) Number K983471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1998
Decision Date February 23, 1999
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
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 84
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K983471.
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
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
COSGROVE CLAMP
K974769 · Allegiance Healthcare Corp. · Jun 1998