FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K Number: K012347
·
Decision Aug 23, 2001
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
8
Review Days
30
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Basic Information
- Device Name
- PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K Number
- K012347
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Sulzer Intratherapeutics, Inc.
- Date Received
- July 24, 2001
- Decision Date
- August 23, 2001
- Product Code
- FGE
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by Sulzer Intratherapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K023243 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Dec 13, 2002 | Substantially Equivalent |
| K021729 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Jun 21, 2002 | Unknown |
| K021563 | INTRACOIL SELF-EXPANDING PERIPHERAL STENT | May 31, 2002 | Substantially Equivalent |
| K020528 | INTRASTENT LD (LARGE DIAMETER) STENT | Apr 16, 2002 | Unknown |
| K014136 | MODIFICATION TO PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Jan 17, 2002 | Unknown |
| K011806 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Sep 7, 2001 | Unknown |
| K012066 | PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | Aug 1, 2001 | Unknown |