JET PORT PLUS CATHETER SYSTEM
FDA 510(k) clearance K000125 · decided 2000-04-12
Clearance details
- K-number
- K000125
- Device name
- JET PORT PLUS CATHETER SYSTEM
- Applicant
- Clinical Plastic Products SA
- Decision
- Substantially Equivalent
- Date received
- 2000-01-18
- Decision date
- 2000-04-12
- Days to decision
- 85 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Rancho Santa Margarita, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| 9F Plastic Dual Port; The port systems are totally implantable vascular access devices. Th recall (Z-1527-2015) | Medical Components, Inc dba MedComp | 2015-04-27 |