FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AuST Steerable Sheath
K Number: K260942
·
Decision Apr 7, 2026
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
13
Review Days
18
Basic Information
- Device Name
- AuST Steerable Sheath
- K Number
- K260942
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CenterPoint Systems, LLC
- Date Received
- March 20, 2026
- Decision Date
- April 7, 2026
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DYB | Introducer, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by CenterPoint Systems, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K261492 | FieldFlex Steerable Sheath | Jun 5, 2026 | Substantially Equivalent |
| K260163 | AuST CSP Introducer | Feb 19, 2026 | Substantially Equivalent |
| K250828 | CPS Locator 3D Plus Delivery Catheter | Jun 27, 2025 | Substantially Equivalent |
| K250492 | FlexiGo 3D Delivery Catheter | Jun 18, 2025 | Substantially Equivalent |
| K251051 | AuST Steerable Sheath | Apr 30, 2025 | Substantially Equivalent |
| K243180 | SSPC NXT Delivery Catheter | Dec 4, 2024 | Substantially Equivalent |
| K242106 | AuST Steerable Sheath | Oct 4, 2024 | Substantially Equivalent |
| K233752 | Dragonfly Pancreaticobiliary Scope; Dragonfly Digital Controller; Dragonfly Instrument Channel Caps | May 2, 2024 | Substantially Equivalent |
| K240829 | AuST Steerable Sheath | May 1, 2024 | Substantially Equivalent |
| K223097 | RenaNav Ureteroscope System | Jul 31, 2023 | Substantially Equivalent |