FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SOFIA EX Intracranial Support Catheter
K Number: K230775
·
Decision Sep 14, 2023
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
91
Applicant Total
85
Review Days
177
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
- SOFIA EX Intracranial Support Catheter
- K Number
- K230775
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MicroVention, Inc.
- Date Received
- March 21, 2023
- Decision Date
- September 14, 2023
- Product Code
- QJP
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| QJP | Catheter, Percutaneous, Neurovasculature | FDA class 2 | Cardiovascular |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QJP), ordered by most recent decision date.
BOBBY Balloon Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Zenith Distal Access Long Sheath
FDA 510(k)
FDA Class 2
·Cardiovascular
SAYA 86 Radial Access Guide Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
BosCATH Support Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
Next Generation 088 Catheter
FDA 510(k)
FDA Class 2
·Cardiovascular
PATH BGC
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by MicroVention, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232542 | Wedge XL Delivery Catheter | May 16, 2024 | Substantially Equivalent |
| K222694 | EmPro EPS (EP4514C-190, EP6514C-190);Nanoparasol EPS (PNP4514C-190,PNP6514C-190) | Apr 27, 2023 | Substantially Equivalent |
| K222115 | ISAAC Neurovascular Navigation Catheter | Jan 10, 2023 | Substantially Equivalent |
| K223050 | AZUR HydroPack 18 (45-880005; 45-880010; 45-880020; 45-880035; 45-880050; 45-880060) | Dec 21, 2022 | Substantially Equivalent |
| K214024 | SOFIA 88 Catheter | Sep 12, 2022 | Substantially Equivalent |
| K211120 | ERIC Retrieval Device | Mar 31, 2022 | Substantially Equivalent |
| K193607 | BOBBY Balloon Guide Catheter | Jul 21, 2020 | Substantially Equivalent |
| K201487 | Traxcess 7 Mini Guidewire | Jul 2, 2020 | Substantially Equivalent |
| K200547 | Traxcess 14 SELECT Guidewire | Apr 16, 2020 | Substantially Equivalent |
| K191680 | AZUR Vascular Plug | Mar 20, 2020 | Substantially Equivalent |