FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
Liverty TIPS Access Set
K Number: K221440
·
Decision May 31, 2022
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
34
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- Liverty TIPS Access Set
- K Number
- K221440
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bard Peripheral Vascular, Inc.
- Date Received
- May 17, 2022
- Decision Date
- May 31, 2022
- Product Code
- DYB
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DYB), ordered by most recent decision date.
FieldFlex Steerable Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Echo Large Bore Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Introducer Sheath Set
FDA 510(k)
FDA Class 2
·Cardiovascular
Edwards eSheath+ introducer set
FDA 510(k)
FDA Class 2
·Cardiovascular
Aventus Introducer Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
Protaryx Transseptal Puncture Device (PTX2-001)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Bard Peripheral Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260012 | UltraScore Focused Force PTA Balloon | Feb 4, 2026 | Substantially Equivalent |
| K252681 | EnCor EnCompass Breast Biopsy and Tissue Removal System | Dec 12, 2025 | Substantially Equivalent |
| K250032 | Marquee Disposable Core Biopsy Instrument and Instrument Kit | Jul 10, 2025 | Substantially Equivalent |
| K250219 | Dorado PTA Balloon Dilatation Catheter | Jun 17, 2025 | Substantially Equivalent |
| K243642 | UltraCor Twirl Breast Tissue Marker | Mar 24, 2025 | Substantially Equivalent |
| K242757 | Rotarex Atherectomy System | Jan 30, 2025 | Substantially Equivalent |
| K241946 | PeritX 1L Drainage Kit (90-1010); PeritX 2L Drainage Kit (90-2010); PeritX Peritoneal Catheter Kit (50-9000C); PeritX Peritoneal Catheter and Starter Kit (50-9900C); PeritX Peritoneal Catheter Mini Kit (50-9050A); PleurX Low Profile Catheter Mini Kit (50-8050); Valve Cap (50-7235A); PeritX Valve Kit (50-7272); Catheter Access Kit (50-7280A); Lockable Drainage Line (50-7245A); Lockable Drainage Line Kit (50-7265A); PleurX Supplemental Insertion Kit (50-7262); Procedure Pack (50- | Dec 6, 2024 | Substantially Equivalent |
| K232737 | PowerPort ClearVUE Slim ECG Enabled Implantable Port; PowerPort ClearVUE isp ECG Enabled Implantable Port; PowerPort isp M.R.I. ECG Enabled Implantable Port; PowerPort Slim ECG Enabled Implantable Port | Dec 8, 2023 | Substantially Equivalent |
| K211410 | GlidePath 13F Long-Term Hemodialysis Catheter | Jun 4, 2021 | Unknown |
| K192948 | EleVation Breast Biopsy Driver, EleVation Breast Biopsy Probe - 10G, EleVation Breast Biopsy Probe - 14G | Nov 7, 2019 | Substantially Equivalent |