Cleared Traditional

K864320 - SENTRON PRESSURE MEASURING CATH/PRESSUR...

K864320 is an FDA 510(k) clearance for SENTRON PRESSURE MEASURING CATH/PRESSUR..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code DRQ cleared through the Traditional 510(k) pathway after a 109-day FDA review.

K864320 · Cordis Corp. · Cardiovascular device
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Feb 1987
Decision
109d
Days
Class 2
Risk

K864320 is an FDA 510(k) clearance for the SENTRON PRESSURE MEASURING CATH/PRESSURE INTERFACE. Classified as Amplifier And Signal Conditioner, Transducer Signal (product code DRQ), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on February 20, 1987 after a review of 109 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2060 - 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 Cordis Corp. devices

FDA 510(k) Submission Details - K864320

510(k) Number K864320 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 03, 1986
Decision Date February 20, 1987
Days to Decision 109 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
16d faster than avg
Panel avg: 125d · This submission: 109d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRQ Device Classification - Class 2, Special Controls

Product Code DRQ Amplifier And Signal Conditioner, Transducer Signal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2060
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 - DRQ Amplifier And Signal Conditioner, Transducer Signal

All 13
Devices cleared under the same product code (DRQ) and FDA review panel - the closest regulatory comparables to K864320.
SIEMENS MEDICAL INFORMATION BUS (MIB II) PROTOCOL CONVERTER
K010640 · Siemens Medical Solutions USA, Inc. · Mar 2001
BARD BIOPOTENTIAL AMPLIFIER II
K901358 · C.R. Bard, Inc. · May 1990
TAKEDA MEDICAL DIGITAL SPHYGMOMANOMETER UA-701
K870728 · A&D Engineering, Inc. · Mar 1987
EXTERNAL VALVE FUNCTION BLOCK
K830914 · Honeywell, Inc. · Aug 1983
TRANSDUCER DOME, CAT.#SD-101
K802961 · Sorensen Research · Dec 1980
DISPOSABLE DIAPHRAGM DONE
K803011 · Sorensen Research · Dec 1980