Super Sheath
FDA 510(k) K141070 · Togo Medikit Co., Ltd.
510(k) numberK141070
Submission
- Device name
- Super Sheath
- Applicant
- Togo Medikit Co., Ltd.
Bunkyo-Ku, JP - Received
- April 25, 2014
- Decision date
- January 15, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
Other 510(k)s with product code DRE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261310 | FlexTract Deflectable-Rotational Dilator Sheath SetDRE · Traditional | Merit Medical Systems, Inc. | 07/27/2026SE |
| K253616 | ProtekDilate Vascular Access KitDRE · Special | Sorin Group Italia S.R.L. | 12/19/2025SE |
| K251325 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 05/29/2025SE |
| K242229 | Micro Ace Gold Advanced Micro Access SystemDRE · Traditional | Merit Medical Systems, Inc. | 01/15/2025SE |
| K241720 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 07/12/2024SE |
| K233647 | VersaCross Connect Transseptal DilatorDRE · Special | Baylis Medical Company, Inc. | 12/14/2023SE |
| K232609 | Micro Ace Advanced Micro Access SystemDRE · Special | Merit Medical Systems, Inc. | 09/27/2023SE |
| K223472 | TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian…DRE · Special | Spectranetics, Inc. | 12/15/2022SE |
| K212784 | TightRail Guardian Motorized Dilator SheathDRE · Traditional | Spectranetics, Inc. | 08/24/2022SE |
| K211679 | Xtractor deviceDRE · Traditional | Xcardia Innovation , Ltd. | 02/17/2022SE |
More from Xcardia Innovation , Ltd.
| 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 |
| K160592 | Supercath 6FOZ · Traditional | 08/12/2016SE |
| 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 Super Sheath cleared by the FDA?
Super Sheath (K141070) received a 510(k) decision of Substantially Equivalent on January 15, 2015, 265 days after the submission was received.
What is the product code of K141070?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.