Cleared Traditional

K964662 - FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20, RMDS 2000-15, RMDS 2000-20, RMDS 3000-15

K964662 is an FDA 510(k) clearance for FAVC: FEMORAL ARTERY VASCULAR CLAMP - M..., 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 74-day FDA review.

K964662 · Rmds, Inc. · Cardiovascular device
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Feb 1997
Decision
74d
Days
Class 2
Risk

K964662 is an FDA 510(k) clearance for the FAVC: FEMORAL ARTERY VASCULAR CLAMP - MODEL NUMBER RMDS 1000-15, RMDS 1000-20.... Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Rmds, Inc. (Vancouver, US). The FDA issued a Cleared decision on February 3, 1997 after a review of 74 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 Rmds, Inc. devices

FDA 510(k) Submission Details - K964662

510(k) Number K964662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 1996
Decision Date February 03, 1997
Days to Decision 74 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
51d faster than avg
Panel avg: 125d · This submission: 74d
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 K964662.
FAVC-M: FEMORAL ARTERY VASCULAR CLAMP-MOBILE (MODEL M100-M200) FAVC-M FEMORAL ARTERY VASCULAR CLAMP-MOBILE ADJ BELT 6005
K970027 · Rmds, Inc. · Aug 1997
OCCLUSION CLAMP** DEVICE
K964251 · United States Surgical, A Division of Tyco Healthc · May 1997
HEARTPORT ENDOAORTIC CLAMP
K964161 · Heartport, Inc. · Apr 1997
DEGANIA SILICONE INDENTI LOOPS
K964547 · Degania Silicone , Ltd. · Jan 1997
HEARTPORT CABLE BULLDOG CLAMP
K962366 · Heartport, Inc. · Nov 1996
AMR-ACV CLAMPS
K962668 · Applied Medical Resources · Nov 1996