Cleared Traditional

K971877 - LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR

K971877 is an FDA 510(k) clearance for LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR, manufactured by Dideco S.P.A.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K971877 · Dideco S.P.A. · Cardiovascular device
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Oct 1997
Decision
140d
Days
Class 2
Risk

K971877 is an FDA 510(k) clearance for the LILLIPUT 2 INFANT HOLLOW FIBER OXYGENATOR. Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Dideco S.P.A. (Waltham, US). The FDA issued a Cleared decision on October 8, 1997 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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 Dideco S.P.A. devices

FDA 510(k) Submission Details - K971877

510(k) Number K971877 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1997
Decision Date October 08, 1997
Days to Decision 140 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
15d slower than avg
Panel avg: 125d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 212
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K971877.
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K974812 · Cobe Cardiovascular, Inc. · Jun 1998
COBE OXYGENATOR PRODUCTS
K974085 · Cobe Cardiovascular, Inc. · Jan 1998
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K963518 · Cobe Cardiovascular, Inc. · Dec 1997
COBE OPTIMA AND COBE CML DUO MEMBRANE OXYGENATORS
K964043 · Cobe Cardiovascular, Inc. · Sep 1997
CAPIOX 308 HOLLOW FIBER OXYGENATOR W/INTEGRATED HEAT EXCHANGE
K961734 · Terumo Medical Corp. · Jul 1997
CAPIOX E HOLLOW FIBER OXYGENATOR WITH INTEGRATED HEAT EXCHANGER/ARTERIAL RESERVOIR
K970463 · Terumo Medical Corp. · May 1997