INTRAN PLUS
FDA 510(k) clearance K905563 · decided 1991-06-19
Clearance details
- K-number
- K905563
- Device name
- INTRAN PLUS
- Applicant
- Utah Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-12-12
- Decision date
- 1991-06-19
- Days to decision
- 189 days
- Clearance type
- Traditional
- Product code
- KXO
- Device class
- 2
- Regulation number
- 884.2700
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Midvale, UT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Intran Plus, Disposable Intrauterine Pressure Catheter System, Part numbers IUP-400, IUP-4 recall (Z-2200-2008) | Utah Medical Products, Inc | 2008-09-11 |