FARADRIVE Steerable Sheath
FDA 510(k) K233248 · Boston Scientific Corporation
510(k) numberK233248
Submission
- Device name
- FARADRIVE Steerable Sheath
- Applicant
- Boston Scientific Corporation
St Paul, MN, US - Received
- September 28, 2023
- Decision date
- December 11, 2023
- 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 |
| 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 |
| K190167 | MitraClip G4 Steerable Guide CatheterDRA · Special | Abbott | 05/29/2019SE |
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| K262151 | SpaceOAR Flex SystemOVB · Traditional | 09/11/2026SE |
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| K261153 | LithoVue Elite Digital Flexible Ureteroscope SystemFGB · Traditional | 08/26/2026SE |
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| K262406 | EluPro Antibiotic-Eluting BioEnvelopeFTM · Special | 08/12/2026SE |
| K261915 | Navigator Flex Ureteral Access Sheath SetFED · Traditional | 08/04/2026SE |
| K262462 | TheraSphere 360 Y-90 Management PlatformLLZ · Special | 07/24/2026SE |
| K262165 | FARADRIVE Steerable Sheath (M004PF21M402)DRA · Special | 07/24/2026SE |
| K261488 | OBSIDIO Conformable EmbolicKRD · Traditional | 07/24/2026SE |
| K261978 | WallFlex Esophageal Stent System;Agile Esophageal Over-the-Wire (OTW) Stent SystemESW · Special | 07/10/2026SE |
Questions and answers
When was FARADRIVE Steerable Sheath cleared by the FDA?
FARADRIVE Steerable Sheath (K233248) received a 510(k) decision of Substantially Equivalent on December 11, 2023, 74 days after the submission was received.
What is the product code of K233248?
The FDA product code is DRA – Catheter, Steerable, a Class II (moderate risk) device regulated under 21 CFR 870.1280.