Cleared Traditional

K991897 - CATHETER INNOVATIONS IMPLANTABLE PORT

K991897 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 Traditional 510(k) pathway after a 139-day FDA review.

K991897 · Catheter Innovations, Inc. · General Hospital
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Oct 1999
Decision
139d
Days
Class 2
Risk

K991897 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 October 21, 1999 after a review of 139 days - within the typical 510(k) review window.

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: 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 Catheter Innovations, Inc. devices

FDA 510(k) Submission Details - K991897

510(k) Number K991897 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1999
Decision Date October 21, 1999
Days to Decision 139 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
10d slower than avg
Panel avg: 129d · This submission: 139d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 219
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K991897.
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
PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM
K992697 · Sims Deltec, Inc. · Nov 1999
P.A.S. PORT ELITE IMPLANTABLE VENOUS ACCESS SYSTEM
K992880 · Sims Deltec, Inc. · Oct 1999
BPOS-IVAD STABILIZER
K983480 · Bpos, Inc. · Nov 1998
VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
K982888 · Boston Scientific Corp · Oct 1998