Z FLEX-270TM Steerable Sheath
FDA 510(k) K112541 · Great Batch Medical
510(k) numberK112541
Submission
- Device name
- Z FLEX-270TM Steerable Sheath
- Applicant
- Great Batch Medical
Plymouth, MN, US - Received
- September 1, 2011
- Decision date
- February 7, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRA – Catheter, Steerable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1280
- Specialty
- Cardiovascular
Other 510(k)s with product code DRA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | Boston Scientific Corporation | 07/24/2026SE |
| K250529 | Globe Introducer (601-01001)DRA · Traditional | Kardium, Inc. | 06/03/2025SE |
| K233248 | FARADRIVE Steerable SheathDRA · Traditional | Boston Scientific Corporation | 12/11/2023SE |
| K232321 | FlexCath Contour Steerable SheathDRA · Traditional | Medtronic, Inc. | 10/31/2023SE |
| K223824 | POLARSHEATH Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP Circular Mapping…DRA · Traditional | Boston Scientific Corporation | 03/22/2023SE |
| K221397 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott Medical | 09/28/2022SE |
| K221044 | AcQGuide® VUE Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/05/2022SE |
| K211100 | AcQGuide MAX Steerable SheathDRA · Traditional | Acutus Medical, Inc. | 05/14/2021SE |
| K202620 | FlexCath Advance Steerable Sheath and DilatorDRA · Traditional | Medtronic Cryocath, LP | 11/13/2020SE |
| K192422 | Steerable Introducer 12FDRA · Traditional | Freudenberg Medical, LLC | 10/04/2019SE |
More from Freudenberg Medical, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K181855 | RadialSeal Introducer KitDYB · Traditional | 07/26/2018SE |
| K130559 | Mobicath Bi-Directional Guiding SheathDYB · Special | 05/24/2013SE |
| K122832 | Mobicath Transseptal NeedleDRC · Special | 12/19/2012SE |
| K110051 | Radialsource Transradial Access Introducer KitDYB · Traditional | 02/02/2012SE |
| K111644 | Mobicath Transseptal NeedleDRC · Traditional | 10/03/2011SE |
| K101784 | Mobicath Bi-Directional Guiding Sheath Model 1000182-XXXDYB · Traditional | 11/26/2010SE |
| K102540 | PTFE Portable IntroducerDYB · Special | 11/16/2010SE |
| K093232 | Optiseal Enpath Valved PTFE Peelable IntroducerDYB · Traditional | 03/15/2010SE |
| K093023 | PTFE Peelable IntroducerDYB · Special | 10/29/2009SE |
Questions and answers
When was Z FLEX-270TM Steerable Sheath cleared by the FDA?
Z FLEX-270TM Steerable Sheath (K112541) received a 510(k) decision of Substantially Equivalent on February 7, 2012, 159 days after the submission was received.
What is the product code of K112541?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.