FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
K Number: K082461
·
Decision Oct 2, 2008
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
85
Review Days
36
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
- BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B
- K Number
- K082461
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MicroVention, Inc.
- Date Received
- August 27, 2008
- Decision Date
- October 2, 2008
- Product Code
- HCG
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | FDA class 2 | Neurology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HCG), ordered by most recent decision date.
Numen Helia Coil Embolization System; NumenFR Detachment System
FDA 510(k)
FDA Class 2
·Neurology
Optima Coil System (OptiOne Coil System)
FDA 510(k)
FDA Class 2
·Neurology
Target Detachable Coil
FDA 510(k)
FDA Class 2
·Neurology
InZone IST Detachment System; IZDS Connecting Cable
FDA 510(k)
FDA Class 2
·Neurology
Optima Coil System (Optima Packing Coil System)
FDA 510(k)
FDA Class 2
·Neurology
Numen Coil Embolization System; NumenFR Detachment System
FDA 510(k)
FDA Class 2
·Neurology
Other Clearances by MicroVention, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K232542 | Wedge XL Delivery Catheter | May 16, 2024 | Substantially Equivalent |
| K230775 | SOFIA EX Intracranial Support Catheter | Sep 14, 2023 | 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 |