Cleared Traditional

K964663 - FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F AND PAD6EK-FX

K964663 is an FDA 510(k) clearance for FAVP: FEMORAL ARTERY VASCULAR PAD - MOD..., manufactured by Rmds, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 385-day FDA review.

K964663 · Rmds, Inc. · Cardiovascular device
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Dec 1997
Decision
385d
Days
Class 2
Risk

K964663 is an FDA 510(k) clearance for the FAVP: FEMORAL ARTERY VASCULAR PAD - MODEL NUMBER PAD2EK-01, PAD2EK-2X, PAD5EK.... Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Rmds, Inc. (Vancouver, US). The FDA issued a Cleared decision on December 11, 1997 after a review of 385 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Rmds, Inc. devices

FDA 510(k) Submission Details - K964663

510(k) Number K964663 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1996
Decision Date December 11, 1997
Days to Decision 385 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
260d slower than avg
Panel avg: 125d · This submission: 385d
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 104
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K964663.
FEMOSTOP II DISPOSABLE SET, FEMOSTOP II COMPRESSION ARCH, FEMOSTOP II PUMP, FEMOSTOP II BILATERAL ADAPTER
K980898 · Radi Medical Systems AB · Apr 1998
SURGICAL VASCULAR CLAMP
K973080 · Walter Lorenz Surgical, Inc. · Feb 1998
EZ HOLD 1 LBS., EZ HOLD 2 LBS
K973132 · Tz Medical, Inc. · Jan 1998
FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
K973216 · Rmds, Inc. · Nov 1997
CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
K970638 · Cardiothoracic Systems, Inc. · Oct 1997
ORIGIN CARDIAC STABLIZER OCCLUDER
K970611 · Origin Medsystems, Inc. · Aug 1997