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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 10/22/2018 
FR Recognition Number 3-99
AAMI TIR42:2010
Evaluation of Particulates Associated with Vascular Medical Devices
This technical information report (TIR) addresses vascular exposure to particles arising from the manufacturing environment for vascular medical devices and from the use of vascular medical devices. It is intended to assist vascular medical device manufacturers in determining the source of particulates, establishing product particulate limits, defining appropriate test methods, and assessing the clinical relevance of particulate contamination.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Transition Period
FDA recognition of AAMI TIR42:2010 [Rec# 3-99] will be superseded by recognition of AAMI TIR42:2021 [Rec# 3-172]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 3-99] until December 18, 2022. After this transition period, declarations of conformity to [Rec# 3-99] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
Unclassified Catheter, Percutaneous Transluminal Coronary Angioplasty (Ptca), Cutting/Scoring Class 3 NWX
Unclassified Coronary Drug-Eluting Stent Class 3 NIQ
Unclassified Drug-Coated Peripheral Transluminal Angioplasty Catheter Class 3 PRC
Unclassified Drug-Eluting Peripheral Transluminal Angioplasty Catheter Class 3 ONU
Unclassified Stent, Carotid Class 3 NIM
Unclassified Stent, Coronary Class 3 MAF
Unclassified Stent, Iliac Class 3 NIO
Unclassified Stent, Renal Class 3 NIN
Unclassified Stent, Superficial Femoral Artery Class 3 NIP
Unclassified System, Endovascular Graft, Aortic Aneurysm Treatment Class 3 MIH
Unclassified Transcatheter Septal Occluder Class 3 MLV
Regulation Number Device Name Device Class Product Code
§870.5100 Catheters, Transluminal Coronary Angioplasty, Percutaneous Class 2 LOX
Regulation Number Device Name Device Class Product Code
§870.1330 Wire, Guide, Catheter Class 2 DQX
Regulation Number Device Name Device Class Product Code
§870.1250 Catheter, Angioplasty, Peripheral, Transluminal Class 2 LIT
§870.1250 Catheter, Percutaneous Class 2 DQY
§870.1250 Catheter, Percutaneous, Cutting/Scoring Class 2 PNO
Regulation Number Device Name Device Class Product Code
§870.1210 Catheter, Continuous Flush Class 2 KRA
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry Coronary Drug-Eluting Stents¿ Nonclinical and Clinical Studies, Issued March 2008.

Guidance for Industry and FDA Staff: Non-Clinical Engineering Tests and Recommended Labeling for Intravascular Stents and Associated Delivery Systems, Issued April 2010.

Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document for Certain percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, Issued May 2008.
FDA Technical Contacts
 Dinesh Patwardhan
 Eleni Whatley
Standards Development Organization
AAMI Association for the Advancement of Medical Instrumentation http://www.aami.org
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.