Cleared Traditional

K881780 - VASCUCARE ANGIOPUMP

K881780 is the FDA 510(k) clearance for VASCUCARE ANGIOPUMP by Vascucare, Inc.. It is a Class 2 Cardiovascular device (product code DWB) cleared through the Traditional 510(k) pathway after a 155-day FDA review.

K881780 · Vascucare, Inc. · Cardiovascular device
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Sep 1988
Decision
155d
Days
Class 2
Risk

K881780 is an FDA 510(k) clearance for the VASCUCARE ANGIOPUMP. Classified as Pump, Blood, Cardiopulmonary Bypass, Roller Type (product code DWB), Class II - Special Controls.

Submitted by Vascucare, Inc. (Orangeburg, US). The FDA issued a Cleared decision on September 28, 1988 after a review of 155 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4370 - 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 Vascucare, Inc. devices

Submission Details

510(k) Number K881780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 26, 1988
Decision Date September 28, 1988
Days to Decision 155 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
30d slower than avg
Panel avg: 125d · This submission: 155d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4370
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 - DWB Pump, Blood, Cardiopulmonary Bypass, Roller Type

All 8
Devices cleared under the same product code (DWB) and FDA review panel - the closest regulatory comparables to K881780.
SARNS 800 ROLLER PUMP
K953901 · 3M Health Care, Sarns · Apr 1996
MODIFIED STOCKERT-SHILEY CAPS MULTI. ROLLER PUMP
K890904 · Shiley, Inc. · Apr 1989
STOCKERT-SHILEY MULTIFLOW ROLLER PUMP MODULE
K861714 · Shiley, Inc. · Jul 1986
STOCKERT-SHILEY DOUBLE HEAD PUMP MODULE
K862116 · Shiley, Inc. · Jul 1986
SARNS PULSATILE PUMP
K820729 · 3M Health Care, Sarns · Nov 1982
PUMP MODULES PMO LO-110-PMD 10-210
K822071 · Gambro, Inc. · Aug 1982