Cleared Traditional

K970644 - AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM

K970644 is an FDA 510(k) clearance for AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM, manufactured by Aeroquip Medical Products. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 161-day FDA review.

K970644 · Aeroquip Medical Products · General Hospital
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Jul 1997
Decision
161d
Days
Class 2
Risk

K970644 is an FDA 510(k) clearance for the AEROQUIP SAFESTART (TM) IV CATH (TM) SYSTEM. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Aeroquip Medical Products (Ann Arbor, US). The FDA issued a Cleared decision on July 31, 1997 after a review of 161 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 Aeroquip Medical Products devices

FDA 510(k) Submission Details - K970644

510(k) Number K970644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1997
Decision Date July 31, 1997
Days to Decision 161 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
32d slower than avg
Panel avg: 129d · This submission: 161d
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 385
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K970644.
VYGON UMBILICAL CATHETHER INSERTION TRAY
K963196 · Vygon Corp. · Sep 1997
ARROWGARD BLUE QUAD-LUMEN CENTRAL VENOUS CATHETER
K962577 · Arrow Intl., Inc. · Aug 1997
AEROQUIP SAFESTART IV CATHETER
K970669 · Aeroquip Medical Products · Aug 1997
SAFE-CATH
K960764 · Scientific Device Manufacturer, LLC · Apr 1997
V-CATH
K964966 · Hdc Corp. · Mar 1997
CVP POLYURETHANE CATHETER
K961552 · Abbott Laboratories · Feb 1997