Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets
FDA 510(k) K121504 · Togo Medikit Co., Ltd.
510(k) numberK121504
Submission
- Device name
- Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets
- Applicant
- Togo Medikit Co., Ltd.
Austin, TX, US - Received
- May 21, 2012
- Decision date
- September 27, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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|---|---|---|---|
| K253526 | NAMIC Dilator and SheathDYB · Traditional | Medline Industries, LP | 07/29/2026SE |
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| K261242 | SimplGuideDYB · Traditional | Pendracare | 06/25/2026SE |
| K261950 | Health Line Tearaway IntroducerDYB · Traditional | Health Line International Corporation | 06/22/2026SE |
| K261492 | FieldFlex Steerable SheathDYB · Special | CenterPoint Systems, LLC | 06/05/2026SE |
| K260606 | Echo Large Bore Introducer SheathDYB · Traditional | Echo Medical, LLC | 04/29/2026SE |
| K254248 | Introducer Sheath SetDYB · Traditional | Cardiocycle Medical(Suzhou) Co., Ltd. | 04/23/2026SE |
| K254279 | Edwards eSheath+ introducer setDYB · Traditional | Edwards Lifesciences | 04/17/2026SE |
| K260091 | Aventus Introducer SheathDYB · Traditional | Inquis Medical | 04/13/2026SE |
| K260839 | Protaryx Transseptal Puncture Device (PTX2-001)DYB · Traditional | Protaryx Medical, Inc. | 04/10/2026SE |
More from Protaryx Medical, 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 |
| K160592 | Supercath 6FOZ · Traditional | 08/12/2016SE |
| K141070 | Super SheathDRE · Traditional | 01/15/2015SE |
| K140419 | SUPERCATH5FOZ · Traditional | 05/12/2014SE |
| 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 Introducer Sheath and Super Sheath Introducer Sheath Sets cleared by the FDA?
Super Sheath Introducer Sheath and Super Sheath Introducer Sheath Sets (K121504) received a 510(k) decision of Substantially Equivalent on September 27, 2012, 129 days after the submission was received.
What is the product code of K121504?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.