Cleared Traditional

K770821 - PUMP

K770821 is the FDA 510(k) clearance for PUMP by Avco Medical Products. It is a Class 2 Cardiovascular device (product code DSP) cleared through the Traditional 510(k) pathway after a 2-day FDA review.

K770821 · Avco Medical Products · Cardiovascular device
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May 1977
Decision
2d
Days
Class 2
Risk

K770821 is an FDA 510(k) clearance for the PUMP, BALLOON, INTRA-AORTIC, TRI-SEGMENT. Classified as System, Balloon, Intra-aortic And Control (product code DSP), Class II - Special Controls.

Submitted by Avco Medical Products (Mchenry, US). The FDA issued a Cleared decision on May 6, 1977 after a review of 2 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3535 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K770821 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1977
Decision Date May 06, 1977
Days to Decision 2 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d faster than avg
Panel avg: 125d · This submission: 2d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSP System, Balloon, Intra-aortic And Control
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3535
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.