FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SUPER SHEATH INTRODUCER SHEATH
K Number: K052557
·
Decision Jan 17, 2006
Classifications
1
FEI Numbers
100
Registration Numbers
100
Same Product Code
103
Applicant Total
17
Review Days
123
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Basic Information
- Device Name
- SUPER SHEATH INTRODUCER SHEATH
- K Number
- K052557
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1310
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Togo Medikit Co., Ltd.
- Date Received
- September 16, 2005
- Decision Date
- January 17, 2006
- Product Code
- DRE
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRE | Dilator, Vessel, For Percutaneous Catheterization | FDA class 2 | Cardiovascular |
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Other Clearances by Togo Medikit Co., Ltd.
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|---|---|---|---|
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| K200379 | Super Sheath | Mar 19, 2020 | Substantially Equivalent |
| K190001 | Supercath 5 | Sep 20, 2019 | Substantially Equivalent |
| K172496 | SUPERCATH 5 (26G) | Mar 23, 2018 | Substantially Equivalent |
| K160592 | SUPERCATH 6 | Aug 12, 2016 | Substantially Equivalent |
| K141070 | SUPER SHEATH | Jan 15, 2015 | Substantially Equivalent |
| K140419 | SUPERCATH5 | May 12, 2014 | Substantially Equivalent |
| K121504 | SUPER SHEATH INTRODUCER SHEATH AND SUPER SHEATH INTRODUCER SHEATH SETS | Sep 27, 2012 | Substantially Equivalent |
| K112290 | SUPERCATH Z3V | Apr 16, 2012 | Substantially Equivalent |
| K093546 | SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX | Dec 17, 2009 | Substantially Equivalent |