Cleared Traditional

K970638 - CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT

K970638 is an FDA 510(k) clearance for CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT, manufactured by Cardiothoracic Systems, Inc.. The device is a Class 2 Cardiovascular device with product code DXC cleared through the Traditional 510(k) pathway after a 252-day FDA review.

K970638 · Cardiothoracic Systems, Inc. · Cardiovascular device
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Oct 1997
Decision
252d
Days
Class 2
Risk

K970638 is an FDA 510(k) clearance for the CTS MIDCAB FIXEDN DIAMETER CORONARY SHUNT. Classified as Clamp, Vascular (product code DXC), Class II - Special Controls.

Submitted by Cardiothoracic Systems, Inc. (Cupertino, US). The FDA issued a Cleared decision on October 30, 1997 after a review of 252 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 Cardiothoracic Systems, Inc. devices

FDA 510(k) Submission Details - K970638

510(k) Number K970638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1997
Decision Date October 30, 1997
Days to Decision 252 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
127d slower than avg
Panel avg: 125d · This submission: 252d
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 K970638.
EZ HOLD 1 LBS., EZ HOLD 2 LBS
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K964663 · Rmds, Inc. · Dec 1997
FAVC-HH: FEMORAL ARTERY VASCULAR CLAMP-HAND HELD: 1/2 & 3 POUNDS (RMDS810T/815T/820T)
K973216 · Rmds, Inc. · Nov 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
OCCLUSION CLAMP** DEVICE
K964251 · United States Surgical, A Division of Tyco Healthc · May 1997