Cleared Traditional

K934939 - TEMPORARY SCREENING LEAD/ CATHETER KIT (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934939 · Medtronic Vascular · General Hospital
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May 1995
Decision
583d
Days
Class 2
Risk

K934939 is an FDA 510(k) clearance for the TEMPORARY SCREENING LEAD/ CATHETER KIT. Classified as Catheter, Percutaneous, Intraspinal, Short Term (product code MAJ), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on May 24, 1995 after a review of 583 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 868.5120 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General Hospital submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K934939 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 18, 1993
Decision Date May 24, 1995
Days to Decision 583 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
455d slower than avg
Panel avg: 128d · This submission: 583d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MAJ Catheter, Percutaneous, Intraspinal, Short Term
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5120
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 General Hospital devices follow this clearance model.