THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM
FDA 510(k) clearance K933350 · decided 1994-02-23
Clearance details
- K-number
- K933350
- Device name
- THEREX LOW-PROFILE PORT 1.5MM I.D. X 2.7MM O.D. DETACHED CATHETER SYSTEM
- Applicant
- Therex Corp.
- Decision
- Unknown
- Date received
- 1993-07-09
- Decision date
- 1994-02-23
- Days to decision
- 229 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-0281-2007) | Arrow International Inc | 2006-12-19 |