FlexCath Select Steerable Shealth and Dilator
FDA 510(k) K163268 · Medtronic Cryocath, LP
510(k) numberK163268
Submission
- Device name
- FlexCath Select Steerable Shealth and Dilator
- Applicant
- Medtronic Cryocath, LP
Mounds View, MN, US - Received
- November 21, 2016
- Decision date
- February 2, 2017
- 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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| 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 |
|---|---|---|
| K202620 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | 11/13/2020SE |
| K183174 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | 11/26/2018SE |
| K142684 | FlexCath Select Steerable Sheath (10 French)DYB · Traditional | 11/06/2014SE |
| K123591 | Flexcath Advance Steerable Sheath (12 French)DRA · Special | 12/27/2012SE |
| K102176 | Flexcath Steerable Sheath (12 French), Flexcath Steerable Sheath (10 French) Model…DRA · Special | 09/01/2010SE |
Questions and answers
When was FlexCath Select Steerable Shealth and Dilator cleared by the FDA?
FlexCath Select Steerable Shealth and Dilator (K163268) received a 510(k) decision of Substantially Equivalent on February 2, 2017, 73 days after the submission was received.
What is the product code of K163268?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.