Cleared Traditional

K843412 - FLOW DIRECTED THERMODILUTION CATH W/VEN

K843412 is the FDA 510(k) clearance for FLOW DIRECTED THERMODILUTION CATH W/VEN by Andover Medical, Inc.. It is a Class 2 Cardiovascular device (product code KRB) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K843412 · Andover Medical, Inc. · Cardiovascular device
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Nov 1984
Decision
81d
Days
Class 2
Risk

K843412 is an FDA 510(k) clearance for the FLOW DIRECTED THERMODILUTION CATH W/VEN. Classified as Probe, Thermodilution (product code KRB), Class II - Special Controls.

Submitted by Andover Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on November 20, 1984 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1915 - 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 Andover Medical, Inc. devices

Submission Details

510(k) Number K843412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1984
Decision Date November 20, 1984
Days to Decision 81 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 125d · This submission: 81d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KRB Probe, Thermodilution
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1915
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 - KRB Probe, Thermodilution

All 11
Devices cleared under the same product code (KRB) and FDA review panel - the closest regulatory comparables to K843412.
VOLUMEVIEW SYSTEM, MODELS VLV520FT6R, VLV520FT8R, VLV520FT6R5
K100739 · Edwards Lifesciences, LLC · Dec 2010
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K936182 · Ohmeda Medical · Mar 1994
THERMOSET(TM) CLOSED LOOP DELIVERY SYSTEM
K884318 · Abbott Laboratories · Dec 1988
FLOW-DIRECTED THERMODILUTION CATHETER
K812800 · Sorensen Research · Oct 1981
SWAN-GANZ HEPARIN COATED, ETC. CATHETER
K811411 · American Edwards Laboratories · Jun 1981
EDSLAB CLOSED INJECTATE DELIVERY SYSTEM
K811399 · American Edwards Laboratories · Jun 1981