Cleared Traditional

K901263 - NAVION SMART-WIRE(TM) CATHETER LOCATION...

K901263 is an FDA 510(k) clearance for NAVION SMART-WIRE(TM) CATHETER LOCATION..., manufactured by Navion Biomedical Corp.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 159-day FDA review.

K901263 · Navion Biomedical Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1990
Decision
159d
Days
Class 2
Risk

K901263 is an FDA 510(k) clearance for the NAVION SMART-WIRE(TM) CATHETER LOCATION SYSTEM. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Navion Biomedical Corp. (Holbrook, US). The FDA issued a Cleared decision on August 22, 1990 after a review of 159 days - an extended review cycle.

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 Navion Biomedical Corp. devices

FDA 510(k) Submission Details - K901263

510(k) Number K901263 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 1990
Decision Date August 22, 1990
Days to Decision 159 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
30d slower than avg
Panel avg: 129d · This submission: 159d
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 279
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K901263.
KENDALL SAFETRAK(TM) HIGH FLOW CATHETER
K903732 · Kendall Healthcare Products Co. Div.Of Tyco Health · Oct 1990
VAS-CATH TRIFUSION TRIPLE LUMEN INFUSION CATHETER
K895597 · Vas-Cath, Inc. · Sep 1990
SPLIT-SECOND INTRODUCER
K902527 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1990
CATHETER WITH GUIDEWIRE ASSEMBLY DEVICE
K900056 · Abbott Laboratories · Aug 1990
MULTICATH PLACEMENT KIT
K901640 · Vygon Corp. · Aug 1990
ANTIMICROBIAL MULTI-LUMEN CENTRAL VENOUS CATHETER
K900263 · Arrow Intl., Inc. · Jul 1990