Cleared Traditional

K901780 - RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE

K901780 is an FDA 510(k) clearance for RTM 36-05, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DSA cleared through the Traditional 510(k) pathway after a 175-day FDA review.

K901780 · Medtronic Vascular · Cardiovascular device
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Oct 1990
Decision
175d
Days
Class 2
Risk

K901780 is an FDA 510(k) clearance for the RTM 36-05, 60-05, RTD 36-05, 60-05 RADIO. LEADWIRE. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Medtronic Vascular (Haverhill, US). The FDA issued a Cleared decision on October 9, 1990 after a review of 175 days - an extended review cycle.

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 Medtronic Vascular devices

FDA 510(k) Submission Details - K901780

510(k) Number K901780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1990
Decision Date October 09, 1990
Days to Decision 175 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
50d slower than avg
Panel avg: 125d · This submission: 175d
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 71
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K901780.
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