INTRAN PLUS
FDA 510(k) clearance K955443 · decided 1996-02-20
Clearance details
- K-number
- K955443
- Device name
- INTRAN PLUS
- Applicant
- Utah Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-11-28
- Decision date
- 1996-02-20
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- HFN
- 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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| Record | Firm | Date |
|---|---|---|
| Koala Intrauterine Pressure Catheter (IPC-5000E) (K250897) | Clinical Innovations, LLC | 2025-05-22 |
| KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETER (K974389) | Clinical Innovations, Inc. | 1998-02-19 |
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| INTRAN 500 (K961424) | Utah Medical Products, Inc. | 1996-07-10 |
| STORC INTRAUTERINE PRESSURE CATHETER (K954955) | Clinical Innovations, Inc. | 1996-04-17 |
| DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCER (K920375) | Telos Medical Corp. | 1992-10-27 |
| ULTRANS DISPOSABLE INTRAUTERINE (K882224) | Telos Medical Corp. | 1989-10-12 |
| SOFSENS(TM) MODEL LMP-100 INTRAUTERINE PRES. TRANS (K893503) | Laurel Medical Corp. | 1989-06-12 |
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 |