FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
VASCULAR SONO
K Number: K113196
·
Decision Feb 6, 2012
Classifications
1
FEI Numbers
273
Registration Numbers
273
Same Product Code
701
Applicant Total
44
Review Days
98
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
- VASCULAR SONO
- K Number
- K113196
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1340
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PAJUNK GmbH Medizintechnologie
- Date Received
- October 31, 2011
- Decision Date
- February 6, 2012
- 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 |
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 PAJUNK GmbH Medizintechnologie
| K Number | Device Name | ||
|---|---|---|---|
| K243690 | SonoMSK | Jul 1, 2025 | Substantially Equivalent |
| K243682 | SonoPlex STIM; SonoPlex II | Jun 27, 2025 | Substantially Equivalent |
| K250774 | SPROTTE® STANDARD (LUER/ NRFit®) Lumbar Puncture | Jun 25, 2025 | Substantially Equivalent |
| K243525 | SonoTAP and SonoTAP II | Mar 24, 2025 | Substantially Equivalent |
| K241953 | SPROTTE® STANDARD (LUER/ NRFit®) Anesthesiology | Nov 22, 2024 | Substantially Equivalent |
| K241954 | SonoBlock; SonoBlock II | Sep 11, 2024 | Substantially Equivalent |
| K230701 | Stim2Go | Nov 24, 2023 | Substantially Equivalent |
| K230201 | Disposable Pre-calibrated Brain Biopsy Needle 2.0 | Feb 22, 2023 | Substantially Equivalent |
| K220897 | Disposable Brain Biopsy Needle 2.0 | Aug 17, 2022 | Substantially Equivalent |
| K202699 | E-Cath STIM acc. Tsui | Dec 29, 2020 | Substantially Equivalent |