Supercath 6
FDA 510(k) K160592 · Togo Medikit Co., Ltd.
510(k) numberK160592
Submission
- Device name
- Supercath 6
- Applicant
- Togo Medikit Co., Ltd.
Hyuga City, JP - Received
- March 1, 2016
- Decision date
- August 12, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5200
- Specialty
- General Hospital
Other 510(k)s with product code FOZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260432 | Ruby Intravascular CatheterFOZ · Traditional | Venocare, Inc. | 09/02/2026SE |
| K260165 | Unimpregnated Central Venous CatheterFOZ · Traditional | Spectrum Vascular | 08/10/2026SE |
| K261041 | ClearSafe Closed SystemFOZ · Traditional | MedSource Labs, LLC | 07/10/2026SE |
| K260539 | MedSource QuickSafe Safety IV Catheter; MedSource PurSafe Safety IV CatheterFOZ · Traditional | MedSource Labs, LLC | 07/09/2026SE |
| K253235 | Introcan Safety® Deep Access XL IV CatheterFOZ · Traditional | B.Braun Medical, Inc. | 05/15/2026SE |
| K252137 | BD Insyte IV CatheterFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 04/02/2026SE |
| K252513 | Polywin Safety (14G x 51mm; 16G x 51mm; 18G x 64mm; 20G x 64mm; 20G x 45mm; 22G x 64mm…FOZ · Special | Poly Medicure Limited | 04/01/2026SE |
| K252398 | SURFLO Hybria Closed System Safety IV CatheterFOZ · Traditional | Terumo Medical Products (Hangzhou) Co., Ltd. | 12/17/2025SE |
| K252677 | Polyshield Safety IV CathetersFOZ · Special | Poly Medicure Limited | 11/05/2025SE |
| K251422 | BD Saf-T-Intima Subcutaneous Catheter SystemFOZ · Traditional | Becton Dickinson Infusion Therapy Systems, Inc. | 10/08/2025SE |
More from Becton Dickinson Infusion Therapy Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K241230 | Super Sheath Introducer Sheath S-3N5/1005 S-3N7/1006 S-3W5/1007 S-3W7/1008DYB · Traditional | 09/17/2024SE |
| K200379 | Super SheathDRE · Special | 03/19/2020SE |
| K190001 | Supercath 5FOZ · Traditional | 09/20/2019SE |
| K172496 | Supercath 5 (26G)FOZ · Traditional | 03/23/2018SE |
| K141070 | Super SheathDRE · Traditional | 01/15/2015SE |
| K140419 | SUPERCATH5FOZ · Traditional | 05/12/2014SE |
| K121504 | Super Sheath Introducer Sheath and Super Sheath Introducer Sheath SetsDYB · Traditional | 09/27/2012SE |
| K112290 | Supercath Z3VFOZ · Traditional | 04/16/2012SE |
| K093546 | Supercath 5 Model SP120-XX-XX, SP125-XX-XXFOZ · Special | 12/17/2009SE |
| K081953 | Supercath 5FOZ · Traditional | 03/12/2009SE |
Questions and answers
When was Supercath 6 cleared by the FDA?
Supercath 6 (K160592) received a 510(k) decision of Substantially Equivalent on August 12, 2016, 164 days after the submission was received.
What is the product code of K160592?
The FDA product code is FOZ – Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days, a Class II (moderate risk) device regulated under 21 CFR 880.5200.