FDA 510(k)
FDA class 2
Substantially Equivalent
🇯🇵 Japan
SUPERCATH Z3V
K Number: K112290
·
Decision Apr 16, 2012
Classifications
1
FEI Numbers
204
Registration Numbers
205
Same Product Code
503
Applicant Total
17
Review Days
251
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SUPERCATH Z3V
- K Number
- K112290
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5200
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Togo Medikit Co., Ltd.
- Date Received
- August 9, 2011
- Decision Date
- April 16, 2012
- Product Code
- FOZ
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FOZ | Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (FOZ), ordered by most recent decision date.
Introcan Safety® Deep Access XL IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
BD Insyte IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm; 22G x 45mm; 24G x 32mm; 24G x 14mm, 26G x 14mm); Polywin Safety Adva (20G x 45mm; 22G x 64mm; 22G x 45mm ; 24G x 32 mm; 24G x 14mm; 14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm, 26G x 14mm)
FDA 510(k)
FDA Class 2
·General Hospital
SURFLO Hybria Closed System Safety IV Catheter
FDA 510(k)
FDA Class 2
·General Hospital
Polyshield Safety IV Catheters
FDA 510(k)
FDA Class 2
·General Hospital
BD Saf-T-Intima Subcutaneous Catheter System
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Togo Medikit Co., Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008 | Sep 17, 2024 | Substantially Equivalent |
| 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 |
| K093546 | SUPERCATH 5 MODEL SP120-XX-XX, SP125-XX-XX | Dec 17, 2009 | Substantially Equivalent |
| K081953 | SUPERCATH 5 | Mar 12, 2009 | Substantially Equivalent |