Cleared Special

PLACEMENT-PLUS (K003642) - FDA 510(k) Clearance

Class II General Hospital device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K003642 · Catheter Innovations, Inc. · General Hospital
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Dec 2000
Decision
23d
Days
Class 2
Risk

K003642 is an FDA 510(k) clearance for the PLACEMENT-PLUS. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Catheter Innovations, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on December 20, 2000 after a review of 23 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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.

View all Catheter Innovations, Inc. devices

Submission Details

510(k) Number K003642 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 2000
Decision Date December 20, 2000
Days to Decision 23 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 79
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K003642.
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POLY PER-Q-CATH PICC CATHETER,MODEL 3236100 AND POLY PER-Q-CATH MIDLINE CATHETER, MODEL 3134135
K001901 · C.R. Bard, Inc. · Sep 2000
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K961856 · United States Surgical, A Division of Tyco Healthc · Jul 1996
PER-Q-CATH & PER-Q-CATH DUAL MUMEN CATHETERS, TRAYS & ACCESSORY DEVICES
K954104 · C.R. Bard, Inc. · Nov 1995