Cleared Traditional

K853332 - HDC CHEMO-PORT (VASCULAR)

K853332 is an FDA 510(k) clearance for HDC CHEMO-PORT (VASCULAR), manufactured by Hdc Corp.. The device is a Class 2 General Hospital device with product code LJT cleared through the Traditional 510(k) pathway after a 343-day FDA review.

K853332 · Hdc Corp. · General Hospital
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Jul 1986
Decision
343d
Days
Class 2
Risk

K853332 is an FDA 510(k) clearance for the HDC CHEMO-PORT (VASCULAR). Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Hdc Corp. (Mountain View, US). The FDA issued a Cleared decision on July 17, 1986 after a review of 343 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Hdc Corp. devices

FDA 510(k) Submission Details - K853332

510(k) Number K853332 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1985
Decision Date July 17, 1986
Days to Decision 343 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
214d slower than avg
Panel avg: 129d · This submission: 343d
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 166
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K853332.
HICKMAN(TM) SUBCUTANEOUS PORT W/DETACHED CATHETER
K863750 · C.R. Bard, Inc. · Dec 1986
LIFE-PORT IMPLANTABLE VASCULAR ACCESS
K853827 · Strato Medical Corp. · Nov 1986
HICKMAN SUBCUTANEOUS PORT W/PRE-ATTACHED CATHETER
K863305 · C.R. Bard, Inc. · Oct 1986
MEDTRONIC MODEL 8501 ACCESS PORT
K861498 · Medtronic Vascular · Jun 1986
IMPLANTOFIX
K851293 · Burron Medical Products, Inc. · Jan 1986
MEDTRONIC ACCESS PORT MODEL 8500
K853322 · Medtronic Vascular · Nov 1985