FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
K Number: K003040
·
Decision Dec 28, 2000
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
15
Review Days
90
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Basic Information
- Device Name
- INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY
- K Number
- K003040
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Intratherapeutics, Inc.
- Date Received
- September 29, 2000
- Decision Date
- December 28, 2000
- 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 Intratherapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K011184 | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS | Aug 13, 2001 | Unknown |
| K003997 | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS | Jan 24, 2001 | Unknown |
| K003450 | INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS | Dec 7, 2000 | Unknown |
| K001648 | INTRASTENT DOUBLESTRUT PARAMOUNT | Aug 28, 2000 | Substantially Equivalent |
| K001257 | INTRACOIL STENT | May 18, 2000 | Substantially Equivalent |
| K000864 | INTRASTENT DOUBLESTRUT XS STENT | Apr 14, 2000 | Substantially Equivalent |
| K993904 | INTRASTENT DOUBLESTRUT LD | Feb 1, 2000 | Unknown |
| K992816 | MODIFICATION TO INTRASTENT | Oct 15, 1999 | Unknown |
| K992622 | INTRAMAX ITI GUIDE CATHETER | Sep 29, 1999 | Substantially Equivalent |
| K990592 | INTRASTENT II | Sep 1, 1999 | Unknown |