Cleared Traditional

K882380 - SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS ...

K882380 is the FDA 510(k) clearance for SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS ... by Scimed Life Systems, Inc.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K882380 · Scimed Life Systems, Inc. · Cardiovascular device
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Oct 1988
Decision
119d
Days
Class 2
Risk

K882380 is an FDA 510(k) clearance for the SCIMED MODEL SM-C/VR CARDIOTOMY/VENOUS RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Scimed Life Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 6, 1988 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - 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 Scimed Life Systems, Inc. devices

Submission Details

510(k) Number K882380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1988
Decision Date October 06, 1988
Days to Decision 119 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
6d faster than avg
Panel avg: 125d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
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 - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 126
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K882380.
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872 · Shiley, Inc. · Jan 1989
BLOOD RESERVOIR, CARDIOPULMONARY BYPASS
K882414 · Gish Biomedical, Inc. · Dec 1988
CARDIOTOMY/VENOUS RESERVOIR NO.: CVR SERIES
K883923 · Gish Biomedical, Inc. · Nov 1988
SARNS INFANT VENOUS RESERVOIR MODEL #16387
K883345 · 3M Health Care, Sarns · Sep 1988
SCIMED R30 SILICONE ASSIST RESERVOIR
K882720 · Scimed Life Systems, Inc. · Sep 1988
MAXIMA* COLLAPSIBLE VENOUS RESERVOIR BAG & HOLDER
K873423 · Johnson & Johnson Professionals, Inc. · Nov 1987