Cleared Traditional

K964251 - OCCLUSION CLAMP** DEVICE

K964251 is an FDA 510(k) clearance for OCCLUSION CLAMP** DEVICE, manufactured by United States Surgical, A Division of Tyco Healthc. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K964251 · United States Surgical, A Division of Tyco Healthc · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
211d
Days
Class 2
Risk

K964251 is an FDA 510(k) clearance for the OCCLUSION CLAMP** DEVICE. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Norwalk, US). The FDA issued a Cleared decision on May 23, 1997 after a review of 211 days - an extended review 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: 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 United States Surgical, A Division of Tyco Healthc devices

FDA 510(k) Submission Details - K964251

510(k) Number K964251 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 1996
Decision Date May 23, 1997
Days to Decision 211 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
86d slower than avg
Panel avg: 125d · This submission: 211d
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 168
Devices cleared under the same product code (DXC) and FDA review panel - the closest regulatory comparables to K964251.
CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT
K970638 · Cardiothoracic Systems, Inc. · Oct 1997
ORIGIN CARDIAC STABLIZER OCCLUDER
K970611 · Origin Medsystems, Inc. · Aug 1997
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
HEARTPORT ENDOAORTIC CLAMP
K964161 · Heartport, Inc. · Apr 1997
CTS MIDCAB CORONARY SHUNT
K963503 · Cardiothoracic Systems, Inc. · Apr 1997
MICS DEVICE SYSTEM
K963716 · Percutaneous Technologies, Inc. · Apr 1997