Cleared Special

K993860 - CATHETER INNOVATIONS IMPLANTABLE PORT

K993860 is an FDA 510(k) clearance for CATHETER INNOVATIONS IMPLANTABLE PORT, manufactured by Catheter Innovations, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Special 510(k) pathway after a 18-day FDA review.

K993860 · Catheter Innovations, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 1999
Decision
18d
Days
Class 2
Risk

K993860 is an FDA 510(k) clearance for the CATHETER INNOVATIONS IMPLANTABLE PORT. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Catheter Innovations, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 3, 1999 after a review of 18 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K993860

510(k) Number K993860 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 15, 1999
Decision Date December 03, 1999
Days to Decision 18 days
Submission Type Special
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
111d faster than avg
Panel avg: 129d · This submission: 18d
Pathway characteristics
Modification to existing cleared device.

LJT Device Classification - Class 2, Special Controls

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 265
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K993860.
HORIZON MEDICAL PRODUCTS MICROPORT 2 PERIPHERAL ACCESS PORT SYSTEM
K994196 · Horizon Medical Products, Inc. · Feb 2000
PLASTIC PORT IMPLANTABLE VENOUS ACCESS SYSTEM
K994216 · Sims Deltec, Inc. · Jan 2000
CELSITE, MODELS ST401L, ST405L
K994111 · B. Braun/Mcgaw · Jan 2000
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697 · Sims Deltec, Inc. · Nov 1999
CATHETER INNOVATIONS IMPLANTABLE PORT
K991897 · Catheter Innovations, Inc. · Oct 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · Sims Deltec, Inc. · Oct 1999
K993860 · CATHETER INNOVATIONS IMPLANTABLE PORT
Download PDF FDA Summary Catheter Innovations,…