PREMICATH, 1261.205
FDA 510(k) clearance K041468 · decided 2004-09-09
Clearance details
- K-number
- K041468
- Device name
- PREMICATH, 1261.205
- Applicant
- Vygon Corp.
- Decision
- Substantially Equivalent
- Date received
- 2004-06-02
- Decision date
- 2004-09-09
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- LJS
- Device class
- 2
- Regulation number
- 880.5970
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Norristown, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Premicath 28G PICC Catheter recall (Z-0090-06) | Vygon Corporation | 2005-10-28 |