Cleared Traditional

K062577 - V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC

K062577 is an FDA 510(k) clearance for V1 MULTI-PORT CONNECTOR, manufactured by Tz Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K062577 · Tz Medical, Inc. · Cardiovascular device
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Dec 2006
Decision
106d
Days
Class 2
Risk

K062577 is an FDA 510(k) clearance for the V1 MULTI-PORT CONNECTOR, MODEL PAD V1-MPC. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Tz Medical, Inc. (Portland, US). The FDA issued a Cleared decision on December 15, 2006 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2900 - 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 Tz Medical, Inc. devices

FDA 510(k) Submission Details - K062577

510(k) Number K062577 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 2006
Decision Date December 15, 2006
Days to Decision 106 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSA Device Classification - Class 2, Special Controls

Product Code DSA Cable, Transducer And Electrode, Patient, (including Connector)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2900
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 - DSA Cable, Transducer And Electrode, Patient, (including Connector)

All 60
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K062577.
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