Recognition List Number: 017 Publication Date: 05/21/2007
Part B: SUPPLEMENTARY INFORMATION
Recognition Number 6-171: ISO 10555-3:1996/ Corrigendum 1:2002, Sterile, single-use intravascular catheters - Part 3: Central venous catheters. (General Plastic Surgery/General Hospital)
Date of Standard: 1996. |
| 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: |
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| Processes Affected: |
| 510(k), PMA, IDE, PDP, HDE |
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| Type of Standard: |
| International, Vertical |
| Extent of Recognition: |
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| Related CFR Citations and Product Codes: |
Regulation
Number |
Device Name |
Device
Class |
Product
Code |
| §880.5970 |
Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days |
Class 2 |
LJS |
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| Relevant Guidance: |
| Guidance of Premarket Notification [510(k)] Submission for Short-Term and Long-Term Intravascular Catheters, Issued March 16, 1995 |
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| FDA Technical Contact: |
| William Burdick |
| FDA/CDRH/ODE |
| 10903 New Hampshire Avenue Building 66, Room 2522 |
| Silver Spring MD 20993 |
| 301/796-6286 |
| Email: william.burdick@fda.hhs.gov |
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