FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ITC BUNJI PLATINUM EMBOLIZATION COIL
K Number: K925876
·
Decision Apr 15, 1993
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
184
Applicant Total
28
Review Days
147
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
- ITC BUNJI PLATINUM EMBOLIZATION COIL
- K Number
- K925876
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5950
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Interventional Therapeutics Corp.
- Date Received
- November 19, 1992
- Decision Date
- April 15, 1993
- 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 Interventional Therapeutics Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K960832 | OCCLUSION BALLOON CATHETER | May 29, 1996 | Substantially Equivalent |
| K950398 | CATHETER, BALLOON TYPE | Oct 5, 1995 | Substantially Equivalent |
| K945588 | DISPOSABLE 1CC SYRINGE WITH LUER LOCK | Feb 10, 1995 | Substantially Equivalent |
| K944354 | CONTOUR EMBOLI | Dec 13, 1994 | Substantially Equivalent |
| K930456 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR | Nov 17, 1993 | Substantially Equivalent |
| K914866 | ITC CONTOUR EMBOLI, MODIFICATION | Nov 9, 1993 | Substantially Equivalent |
| K931025 | INTHERM STASIS VALVE SYSTEM | Sep 28, 1993 | Substantially Equivalent |
| K931278 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR | Jul 23, 1993 | Substantially Equivalent |
| K922609 | ITC CATHETERS W/ HYDROMER | Apr 30, 1993 | Substantially Equivalent |
| K925523 | ITC BUNJI PLATINUM EMBOLIZATION COIL | Mar 23, 1993 | Substantially Equivalent |