Cleared Traditional

K972261 - RIVETTI-LEVINSON INSTRALUMINAL SHUNT

K972261 is an FDA 510(k) clearance for RIVETTI-LEVINSON INSTRALUMINAL SHUNT, manufactured by Integra Neurocare, LLC. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K972261 · Integra Neurocare, LLC · Cardiovascular device
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Sep 1997
Decision
90d
Days
Class 2
Risk

K972261 is an FDA 510(k) clearance for the RIVETTI-LEVINSON INSTRALUMINAL SHUNT. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Integra Neurocare, LLC (Pleasant Prairie, US). The FDA issued a Cleared decision on September 15, 1997 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Integra Neurocare, LLC devices

FDA 510(k) Submission Details - K972261

510(k) Number K972261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1997
Decision Date September 15, 1997
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DWF Device Classification - Class 2, Special Controls

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 270
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K972261.
CALIFORNIA MEDICAL LABORATORIES INC. MALLEABLE VENT CATHETER
K981601 · Sorin Group Italia S.R.L. · Jul 1998
CHASE FEMORAL ACCESS CANNULATION SET
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QUEST VESSEL CATHETER
K971928 · Quest Medical, Inc. · Nov 1997
CHASE THORACIC CATHETER
K971023 · Chase Medical, Inc. · Sep 1997
CARDIOPLEGIA ADAPTERS, VESSEL CANULAE, AND AORTIC ROOT CANNULAE
K972503 · Sorin Group Italia S.R.L. · Aug 1997
CHASE BLOOD VESSEL SHUNT
K972665 · Chase Medical, Inc. · Aug 1997