Cleared Traditional

K940634 - MICRO THERAPEUTICS INFUSION CATHETER

K940634 is an FDA 510(k) clearance for MICRO THERAPEUTICS INFUSION CATHETER, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 242-day FDA review.

K940634 · Micro Therapeutics, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
242d
Days
Class 2
Risk

K940634 is an FDA 510(k) clearance for the MICRO THERAPEUTICS INFUSION CATHETER. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Aliso Viejo, US). The FDA issued a Cleared decision on October 14, 1994 after a review of 242 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 Micro Therapeutics, Inc. devices

FDA 510(k) Submission Details - K940634

510(k) Number K940634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1994
Decision Date October 14, 1994
Days to Decision 242 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
113d slower than avg
Panel avg: 129d · This submission: 242d
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 365
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K940634.
INSYTE INTRODUCER CATHETER
K942045 · Becton Dickinson Vascular Access, Inc. · Jan 1995
PRN ADAPTER
K933467 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Dec 1994
CUFF-CATH
K935090 · Ohmeda Medical · Oct 1994
VITAFLON PLUS/VASCULON
K941417 · Hogan & Hartson · Oct 1994
SAFE-PICC CATHETER
K930048 · Menlo Care, Inc. · May 1994
CATH-FINDER
K931073 · Pharmacia Deltec, Inc. · May 1994