Cleared Traditional

K780517 - CARDIOTOMY RESERVOIR

K780517 is the FDA 510(k) clearance for CARDIOTOMY RESERVOIR by Travenol Laboratories, S.A.. It is a Class 2 Cardiovascular device (product code DTN) cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K780517 · Travenol Laboratories, S.A. · Cardiovascular device
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Apr 1978
Decision
13d
Days
Class 2
Risk

K780517 is an FDA 510(k) clearance for the CARDIOTOMY RESERVOIR. Classified as Reservoir, Blood, Cardiopulmonary Bypass (product code DTN), Class II - Special Controls.

Submitted by Travenol Laboratories, S.A. (Mchenry, US). The FDA issued a Cleared decision on April 13, 1978 after a review of 13 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Travenol Laboratories, S.A. devices

Submission Details

510(k) Number K780517 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 1978
Decision Date April 13, 1978
Days to Decision 13 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
112d faster than avg
Panel avg: 125d · This submission: 13d
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 K780517.
SHILEY UTILITY RESERVOIR
K802119 · Shiley, Inc. · Sep 1980
Q220F CARDITOMY RESERVOIR/MODIFIED
K790635 · Bentley Laboratories, Inc. · Apr 1979
DISPOSABLE CARDIOTOMY
K781577 · C.R. Bard, Inc. · Sep 1978
CARDIOTOMY RESERVOIR
K770036 · Shiley, Inc. · Jan 1977
TMO OXYGENATOR RESERVOIR PUMP SET
K760823 · Travenol Laboratories, S.A. · Nov 1976