Cleared Traditional

K904558 - DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL

K904558 is an FDA 510(k) clearance for DUAL LUMEN 5 FR PERIP CENT VEN CATH W/G..., manufactured by Davol, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K904558 · Davol, Inc. · General Hospital
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Feb 1991
Decision
129d
Days
Class 2
Risk

K904558 is an FDA 510(k) clearance for the DUAL LUMEN 5 FR PERIP CENT VEN CATH W/GROSHONG VAL. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on February 11, 1991 after a review of 129 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Davol, Inc. devices

FDA 510(k) Submission Details - K904558

510(k) Number K904558 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received October 05, 1990
Decision Date February 11, 1991
Days to Decision 129 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
At panel average
Panel avg: 129d · This submission: 129d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 399
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