FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
IMPLANTOFIX
K Number: K851293
·
Decision Jan 9, 1986
Classifications
1
FEI Numbers
57
Registration Numbers
57
Same Product Code
287
Applicant Total
41
Review Days
283
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
- IMPLANTOFIX
- K Number
- K851293
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5965
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Burron Medical Products, Inc.
- Date Received
- April 1, 1985
- Decision Date
- January 9, 1986
- Product Code
- LJT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LJT | Port & Catheter, Implanted, Subcutaneous, Intravascular | FDA class 2 | General Hospital |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LJT), ordered by most recent decision date.
FLEXI-PORT Power Injectable Implantable Port
FDA 510(k)
FDA Class 2
·General Hospital
Vaccess CT Low-Profile Power-Injectable Implantable Port; Vaccess CT Power-Injectable Implantable Port; PowerPort duo M.R.I. Implantable Port
FDA 510(k)
FDA Class 2
·General Hospital
PowerPort isp Implantable Port; PowerPort Slim Implantable Port; PowerPort M.R.I. Implantable Port; PowerPort M.R.I. isp Implantable Port
FDA 510(k)
FDA Class 2
·General Hospital
PowerPort ClearVUE Slim Implantable Ports and PowerPort ClearVUE Slim Implantable Ports
FDA 510(k)
FDA Class 2
·General Hospital
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
FDA 510(k)
FDA Class 2
·General Hospital
SmartPort+ Implantable Ports, SmartPort Plastic Implantable Ports
FDA 510(k)
FDA Class 2
·General Hospital
Other Clearances by Burron Medical Products, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K870403 | CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE | May 1, 1987 | Substantially Equivalent |
| K862412 | INTESTOPLANT | Nov 13, 1986 | Substantially Equivalent |
| K861479 | CAVAFIX, CENTRAL VENOUS CATHETER KIT | Jul 1, 1986 | Unknown |
| K860126 | STIMUPLEX, NERVE STIMULATOR | Feb 28, 1986 | Substantially Equivalent |
| K841428 | JEJUNOSTOMY SET FOR TUBE FEEDING | Jul 9, 1984 | Substantially Equivalent |
| K834383 | DUAL-LUMEN LONG TERM CENTRAL VENOUS CAT | May 1, 1984 | Substantially Equivalent |
| K834299 | LONG TERM CENTRAL VENOUS ACCESS CATH | May 1, 1984 | Substantially Equivalent |
| K834473 | MULTI-LUMEN CENTRAL VENOUS CATH. KIT | Apr 30, 1984 | Substantially Equivalent |
| K840179 | CONTINUOUS EPIDURAL ANESTHES. TRAY | Feb 24, 1984 | Substantially Equivalent |
| K840287 | BRACHIAL PLEXUS ANESTHESIA TRAY | Feb 23, 1984 | Substantially Equivalent |