Cleared Traditional

K881745 - INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER

K881745 is an FDA 510(k) clearance for INFUSE-A-PORT RADIOPAQUE POLYURETHANE C..., manufactured by Shiley Infusaid, Inc.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 19-day FDA review.

K881745 · Shiley Infusaid, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1988
Decision
19d
Days
Class 2
Risk

K881745 is an FDA 510(k) clearance for the INFUSE-A-PORT RADIOPAQUE POLYURETHANE CATHETER. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Shiley Infusaid, Inc. (Norwood, US). The FDA issued a Cleared decision on May 11, 1988 after a review of 19 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 Shiley Infusaid, Inc. devices

FDA 510(k) Submission Details - K881745

510(k) Number K881745 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1988
Decision Date May 11, 1988
Days to Decision 19 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
110d faster than avg
Panel avg: 129d · This submission: 19d
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 244
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K881745.
A-PORT IMPLANT VASCULAR ACCESS SYSTEM .6MM/2.29MM
K893460 · Therex Corp. · Jun 1989
A PORT IMPLANT VASCULAR ACCESS SYSTEM - DETACHED
K882230 · Therex Corp. · Jul 1988
LIFEPORT II, MODEL LPS-1100
K881075 · Strato Medical Corp. · Jun 1988
LIFEPORT LOW PROFILE VASCULAR ACCESS PORT W/CATH.
K880305 · Strato Medical Corp. · Apr 1988
PORT-A-CATH(R) IMPLANTABLE DRUG DELIVERY SYSTEM
K875276 · Pharmacia Deltec, Inc. · Apr 1988
A PORT IMPLANTABLE VASCULAR ACCESS SYSTEM
K875214 · Therex Corp. · Feb 1988