THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D
FDA 510(k) clearance K925373 · decided 1993-05-06
Clearance details
- K-number
- K925373
- Device name
- THEREX LOW-PROFILE PORT/1.0MM I.D./1.8MM O.D
- Applicant
- Therex Corp.
- Decision
- Substantially Equivalent
- Date received
- 1992-10-23
- Decision date
- 1993-05-06
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Implantable Vascular Access System -- Infusion Ports with Silicone Rubber Catheter. Latex- recall (Z-0283-2007) | Arrow International Inc | 2006-12-19 |