Cleared Traditional

K932841 - PORT-A-CATH DUAL LUMEN IMPLANTABLE VENO...

K932841 is the FDA 510(k) clearance for PORT-A-CATH DUAL LUMEN IMPLANTABLE VENO... by Pharmacia Deltec, Inc.. It is a Class 2 General Hospital device (product code LJT) cleared through the Traditional 510(k) pathway after a 208-day FDA review.

K932841 · Pharmacia Deltec, Inc. · General Hospital
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Jan 1994
Decision
208d
Days
Class 2
Risk

K932841 is an FDA 510(k) clearance for the PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS. Classified as Port & Catheter, Implanted, Subcutaneous, Intravascular (product code LJT), Class II - Special Controls.

Submitted by Pharmacia Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on January 5, 1994 after a review of 208 days - an extended review 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: 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 Pharmacia Deltec, Inc. devices

Submission Details

510(k) Number K932841 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 11, 1993
Decision Date January 05, 1994
Days to Decision 208 days
Submission Type Traditional
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
79d slower than avg
Panel avg: 129d · This submission: 208d
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 121
Devices cleared under the same product code (LJT) and FDA review panel - the closest regulatory comparables to K932841.
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PORT-A-CATH DUAL LUMEN IMPLANTABLE VENOUS ACCESS S
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PORT-A-CATH IMPLANTABLE VASCULAR ACCESS SYSTEM
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LIFEPORT ATTACHABLE SYSTEM W/INDUCER KIT LPS 5555
K915273 · Strato Medical Corp. · Jul 1993
SNAP-LOCK MICROPORT - REVISED
K924505 · Strato Medical Corp. · Jun 1993
PHARMACIA DELTEC WINGED INFUSION SET
K923019 · Pharmacia Deltec, Inc. · Apr 1993