VYGON LIFEVAC MID-LINE TRAY
FDA 510(k) clearance K954112 · decided 1996-05-09
Clearance details
- K-number
- K954112
- Device name
- VYGON LIFEVAC MID-LINE TRAY
- Applicant
- Vygon Corp.
- Decision
- Substantially Equivalent
- Date received
- 1995-07-31
- Decision date
- 1996-05-09
- Days to decision
- 283 days
- Clearance type
- Traditional
- Product code
- FOZ
- Device class
- 2
- Regulation number
- 880.5200
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Elizabeth, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Nutriline with Peelable Sheath 2 Fr. is a 2 Fr. peripherally inserted catheter (PIC). Incl recall (Z-0849-03) | Vygon Corporation | 2003-05-20 |
| Neonatal Catheter & Insertion Tray is simply a catheter kit that is comprised of the Nutri recall (Z-0850-03) | Vygon Corporation | 2003-05-20 |