Recognition List Number: 028 Publication Date: 03/16/2012
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-265: ISO 10555-1 First edition 1995-06-5, AMENDMENT 2 2004-05-15 Sterile, single-use intravascular catheters - Part 1: General requirements. (General Plastic Surgery/General Hospital)
Date of Standard: 2004. |
| Address of Standards Organization: |
| International Organization for Standardization (ISO)* |
| 1, Rue de Varembe |
| Case Postale 56 |
| CH 1211 Geneva 20, 0 |
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SWITZERLAND
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| CDRH Office and Division Associated with Recognized Standards: |
| OFFICE OF DEVICE EVALUATION (ODE) | | |
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| Devices Affected: |
| Single-Use Intravascular Catheters |
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| Processes Affected: |
| 510(k), PMA, PDP, IDE, HDE |
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| Type of Standard: |
| Vertical, International |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5200 |
Catheter, Umbilical Artery |
Class 2 |
FOS |
| §880.5200 |
Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days |
Class 2 |
FOZ |
| §880.5200 |
Heparin, Vascular Access Flush |
Class 2 |
NZW |
| §880.5200 |
Saline, Vascular Access Flush |
Class 2 |
NGT |
| §880.5200 |
Water, Vascular Access Flush |
Class 2 |
NZX |
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| Relevant Guidance: |
| Guidance on Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 16, 1995 |
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| FDA Technical Contact: |
| Keith Marin |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2567 |
| Silver Spring MD 20993 |
| 301/796-2462 |
| Email: keith.marin@fda.hhs.gov |
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| * In the United States, copies of this standard can be obtained from: |
| American National Standards Institute (ANSI)* |
| 25 West 43rd Street |
| 4th Floor |
| New York, NY 10036 |
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