Cleared Special

K011937 - TRULINE INFUSION CATHETERS

K011937 is an FDA 510(k) clearance for TRULINE INFUSION CATHETERS, manufactured by Micro Therapeutics, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Special 510(k) pathway after a 68-day FDA review.

K011937 · Micro Therapeutics, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2001
Decision
68d
Days
Class 2
Risk

K011937 is an FDA 510(k) clearance for the TRULINE INFUSION CATHETERS. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Micro Therapeutics, Inc. (Irvine, US). The FDA issued a Cleared decision on August 28, 2001 after a review of 68 days - a notably fast clearance cycle.

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

FDA 510(k) Submission Details - K011937

510(k) Number K011937 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2001
Decision Date August 28, 2001
Days to Decision 68 days
Submission Type Special
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
61d faster than avg
Panel avg: 129d · This submission: 68d
Pathway characteristics
Modification to existing cleared device.

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 492
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K011937.
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA, AND SAF-T-INTIMA INTRAVASCULAR CATHETE
K013800 · Becton Dickinson Infusion Therapy Systems, Inc. · Dec 2001
NIPRO SAFELET CATH
K013287 · Nipro Medical Corp. · Dec 2001
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS
K013073 · Becton Dickinson Infusion Therapy Systems, Inc. · Nov 2001
PROTECTIV ACUVANCE IV CATHETER SYSTEM
K012128 · Ethicon Endo-Surgery, Inc. · Aug 2001
0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE
K011982 · Bd · Jul 2001
KEYST0NE MEDICAL PICC CATHETER
K011860 · Keystone Medical · Jun 2001
K011937 · TRULINE INFUSION CATHETERS
Download PDF FDA Summary Micro Therapeutics, I…