Cleared Traditional

K934939 - TEMPORARY SCREENING LEAD/ CATHETER KIT

K934939 is the FDA 510(k) clearance for TEMPORARY SCREENING LEAD/ CATHETER KIT by Medtronic Vascular. It is a Class 2 General Hospital device (product code MAJ) cleared through the Traditional 510(k) pathway after a 583-day FDA review.

K934939 · Medtronic Vascular · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
454d slower than avg
Panel avg: 129d · 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.

Regulatory Peers - MAJ Catheter, Percutaneous, Intraspinal, Short Term

Devices cleared under the same product code (MAJ) and FDA review panel - the closest regulatory comparables to K934939.
MEDTRONIC ALGOLINE INTRASPINAL CATHETER SYSTEM
K965251 · Medtronic Vascular · Mar 1997
MEDTRONIC MODEL 3864C & 3865C TEMPORARY SCREENING LEAD/CATHETER KIT
K945413 · Medtronic Vascular · May 1995
IPI ALGO-LINE CATHETER
K911382 · Pudenz-Schulte Medical Research Corp. · Jul 1991
LIFECARE CONT. EPIDURAL CATH. FOR MORPHINE SULFATE
K893766 · Abbott Laboratories · Nov 1989