Cleared Traditional

K880323 - MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR

K880323 is an FDA 510(k) clearance for MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR, 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 56-day FDA review.

K880323 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1988
Decision
56d
Days
Class 2
Risk

K880323 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR. Classified as Cable, Transducer And Electrode, Patient, (including Connector) (product code DSA), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on March 22, 1988 after a review of 56 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K880323

510(k) Number K880323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1988
Decision Date March 22, 1988
Days to Decision 56 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
69d faster than avg
Panel avg: 125d · This submission: 56d
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 105
Devices cleared under the same product code (DSA) and FDA review panel - the closest regulatory comparables to K880323.
MEDTRONIC MODEL 5411B SURGICAL CABLE ADAPTOR
K885101 · Medtronic Vascular · Jan 1989
MODIFIED MODEL 5455 DISPOSABLE SURGICAL CABLE
K882174 · Medtronic Andover Medical, Inc. · Jul 1988
ELECTRODE CABLE
K880320 · Vital Connections, Inc. · Mar 1988
BSK-1033 TELEMETRY MONITORING CABLE
K873492 · Desco Industries, Inc. · Oct 1987
ADAPTAID TEMP. PACING EXT. LEAD #366-02
K820268 · Intermedics, Inc. · Mar 1982
CORROSION PROOF SNAP ECG CONNECT WIRES
K802236 · Custom Cardio Components · Oct 1980
K880323 · MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR
Download PDF Medtronic Vascular