Cleared Traditional

K850888 - PERCUTANEOUS CV CATHETER INSERTION KIT ...

K850888 is the FDA 510(k) clearance for PERCUTANEOUS CV CATHETER INSERTION KIT ... by Creative Care Systems, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K850888 · Creative Care Systems, Inc. · General Hospital
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May 1985
Decision
64d
Days
Class 2
Risk

K850888 is an FDA 510(k) clearance for the PERCUTANEOUS CV CATHETER INSERTION KIT W OR W/O CV. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Creative Care Systems, Inc. (Maplewood, US). The FDA issued a Cleared decision on May 7, 1985 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5965 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Creative Care Systems, Inc. devices

Submission Details

510(k) Number K850888 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1985
Decision Date May 07, 1985
Days to Decision 64 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 129d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJT Port & Catheter, Implanted, Subcutaneous, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5965
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 - LJT Port & Catheter, Implanted, Subcutaneous, Intravascular

All 62
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K850888.
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305 · C.R. Bard, Inc. · Oct 1986
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · Medtronic Vascular · Jun 1986
MEDTRONIC ACCESS PORT MODEL 8500
K853322 · Medtronic Vascular · Nov 1985
PORT-A-CATH
K832917 · Pharmacia, Inc. · Dec 1983
PORT-A-CATH IMPLANTABLE CATH. SYS
K830730 · Pharmacia, Inc. · Jun 1983