Lifetrace Intrauterine Pressure Catheter Iup 3000
FDA 510(k) K950708 · Graphic Controls Corp.
510(k) numberK950708
Submission
- Device name
- Lifetrace Intrauterine Pressure Catheter Iup 3000
- Applicant
- Graphic Controls Corp.
Buffalo, NY, US - Received
- February 13, 1995
- Decision date
- May 25, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KXO – Monitor, Pressure, Intrauterine
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 884.2700
- Specialty
- Obstetrics/Gynecology
Other 510(k)s with product code KXO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991235 | Softrans Temp Intrauterine Pressure Catheter System (Iup 5000, Softrans Temp Iupc)KXO · Traditional | Ludlow Technical Products | 07/08/1999SE |
| K982565 | Easy Trans TipKXO · Traditional | Carl Schuh | 09/22/1998SE |
| K974730 | Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional | Graphic Controls Corp. | 07/14/1998SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | Graphic Controls Corp. | 01/22/1997SE |
| K961290 | Iup - Tip Trans, Iup - Proxi TransKXO · Traditional | Scientific Device Manufacturer, LLC | 10/15/1996SE |
| K950498 | Life Trace Trans Tip Intrauterine Pressure CatheterKXO · Traditional | Graphic Controls Corp. | 07/24/1995SE |
| K922323 | MX4042/MC4044 Series Simulcath(Tm)KXO · Traditional | Medex, Inc. | 06/14/1994SE |
| K920044 | Dual Lumen Transcerivical Intrauterine KitKXO · Traditional | Telos Medical Corp. | 04/03/1992SE |
| K910742 | Medi-Trace Disposable Intrauterine CatheterKXO · Traditional | Graphic Controls Corp. | 01/14/1992SE |
| K905563 | Intran PlusKXO · Traditional | Utah Medical Products, Inc. | 06/19/1991SE |
More from Utah Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981964 | Medi-Trace 4103 Neonatal ElectrodeDRX · Traditional | 11/13/1998SE |
| K983287 | Medi-Trace 1610C Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 11/05/1998SE |
| K974730 | Softrans Plus Intrauterine Pressure Catheter System (Iup 5000, Softrans Plus Iupc)KXO · Traditional | 07/14/1998SE |
| K980857 | Medi-Trace 1310P Combination Defibrillation, Monitoring & Pacing ElectrodeMKJ · Traditional | 05/12/1998SE |
| K972970 | Medi-Trace 1510M Combination Defibrillation, Monitoring and Pacing ElectrodeMKJ · Traditional | 08/27/1997SE |
| K964387 | Point of Use II Sharps-A-GatorMMK · Traditional | 03/27/1997SE |
| K964279 | Softrans Intrauterine Pressure Catheter System (Iup 4000 Softrans Iupc)KXO · Traditional | 01/22/1997SE |
| K963151 | Medi-Trace 5700 Resting ECG ElectrodeDRX · Traditional | 11/19/1996SE |
| K963038 | Medi-Trace 3600 Series of ECG Monitoring ElectrodeDRX · Traditional | 11/15/1996SE |
| K960968 | Medi-Trace 200, Medi-Trace 200-30DRX · Traditional | 10/28/1996SE |
Questions and answers
When was Lifetrace Intrauterine Pressure Catheter Iup 3000 cleared by the FDA?
Lifetrace Intrauterine Pressure Catheter Iup 3000 (K950708) received a 510(k) decision of Substantially Equivalent on May 25, 1995, 101 days after the submission was received.
What is the product code of K950708?
The FDA product code is KXO – Monitor, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.