Cleared Traditional

PICC CATHETER/MIDLINE CATHETER (K964447) - FDA 510(k) Clearance

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

K964447 · Menlo Care, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1997
Decision
161d
Days
Class 2
Risk

K964447 is an FDA 510(k) clearance for the PICC CATHETER/MIDLINE CATHETER. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Menlo Care, Inc. (Menlo Park, US). The FDA issued a Cleared decision on April 16, 1997 after a review of 161 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Menlo Care, Inc. devices

Submission Details

510(k) Number K964447 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1996
Decision Date April 16, 1997
Days to Decision 161 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
32d slower than avg
Panel avg: 129d · This submission: 161d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 79
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K964447.
POLY PER-Q-CATH SINGLE LUMEN PICC CATHETER, MODEL 3143100
K012902 · C.R. Bard, Inc. · Sep 2001
CENTRAL VENOUS CATHETER
K003839 · Boston Scientific Corp · Aug 2001
POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
K001901 · C.R. Bard, Inc. · Sep 2000
AUTO SUTURE CHEMOSITE TUNNELER
K961856 · United States Surgical, A Division of Tyco Healthc · Jul 1996
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104 · C.R. Bard, Inc. · Nov 1995
DESERET(R) INTRODUCER SET WITH VITACUFF(R) DEVICE
K893126 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1989