| ISO 10555-1 Second edition 2013-06-15 Intravascular catheters - Sterile and single-use intravascular catheters - Part 1: General requirements [Including AMENDMENT 1 (2017)] |
| Recognition Number | General Plastic Surgery/General Hospital |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 6-408 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized When this standard is used to support a regulatory submission for an interventional or diagnostic cardiovascular catheter (e.g. balloon angioplasty catheter or stent delivery system), Section 4.6 (Peak Tensile Force) is not recognized. |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Keith Marin FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-2462 keith.marin@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies. This standard is recognized in part because "Section 4.6 (Peak Tensile Force)" is in conflict with an existing published final guidance, see Section VII.B. of the FDA Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, issued September 8, 2010.
ISO 10555-1:2013 specifies general requirements for intravascular catheters, supplied in the sterile condition and intended for single use, for any application.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.5970 | Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days | Class 2 | LJS |
| §880.5200 | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | Class 2 | FOZ |
| §880.5200 | Catheter, Umbilical Artery | Class 2 | FOS |
| §880.5200 | Central Venous Catheter Dressing Change Kit | Class 2 | PEZ |
| §880.5200 | Heparin Flush In 0.45% Sodium Chloride | Class 2 | PEF |
| §880.5200 | Heparin, Vascular Access Flush | Class 2 | NZW |
| §880.5200 | Peripheral Catheter Insertion Kit | Class 2 | OWL |
| §880.5200 | Saline, Vascular Access Flush | Class 2 | NGT |
| §880.5200 | Water, Vascular Access Flush | Class 2 | NZX |
| §870.1250 | Catheter, Angioplasty, Peripheral, Transluminal | Class 2 | LIT |
| §870.1250 | Catheter, Percutaneous | Class 2 | DQY |
| Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 1995. Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters, Issued September 2010. |