FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
K Number: K060557
·
Decision Aug 15, 2006
Classifications
1
FEI Numbers
143
Registration Numbers
143
Same Product Code
473
Applicant Total
11
Review Days
166
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Basic Information
- Device Name
- SURESAVE TM SELF-EXPANDABLE NITINOL STENT AND PRECISION TM DELIVERY CATHETER-SS06120060
- K Number
- K060557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5010
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Unknown
- Statement or Summary
- Summary
- Applicant
- Idev Technologies, Inc.
- Date Received
- March 2, 2006
- Decision Date
- August 15, 2006
- 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 Idev Technologies, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K130591 | SUPERA VERITAS | May 2, 2013 | Unknown |
| K122546 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Dec 7, 2012 | Unknown |
| K111627 | SUPERA VERITAS(R) INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Aug 21, 2012 | Unknown |
| K111766 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPTIC BILIARY SYSTEMS | Oct 19, 2011 | Unknown |
| K093893 | SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM | Oct 5, 2010 | Unknown |
| K071646 | SUPERA INTERWOVEN SELF-EXPANDING BILIARY NITINOL STENT DELIVERY CATHETER, MODEL # S-04-040-120 | Jan 31, 2008 | Unknown |
| K050926 | TEXAN LONGHORN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30120060 | May 9, 2005 | Substantially Equivalent |
| K041374 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 | Mar 2, 2005 | Substantially Equivalent |
| K033188 | TEXAN FOREIGN BODY RETRIEVAL DEVICE, MODEL TX30060050 | Nov 19, 2003 | Substantially Equivalent |
| K030504 | AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060 | Sep 16, 2003 | Substantially Equivalent |