Amnicathdl(Tm) DT-IUPC2 Dual Lumen Trans. Tipped
FDA 510(k) K896122 · Spectramed, Inc.
510(k) numberK896122
Submission
- Device name
- Amnicathdl(Tm) DT-IUPC2 Dual Lumen Trans. Tipped
- Applicant
- Spectramed, Inc.
Oxnard, CA, US - Received
- October 24, 1989
- Decision date
- January 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K950708 | Lifetrace Intrauterine Pressure Catheter Iup 3000KXO · Traditional | Graphic Controls Corp. | 05/25/1995SE |
| 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 |
More from Graphic Controls Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K892941 | Cco System Model SP1467,SP5567,SP6267KRB · Traditional | 11/06/1989SE |
| K895323 | Model Dt-Bal, Balance SaverKXO · Traditional | 10/24/1989SE |
| K894362 | Model DT-IUPC2 Transducer Tipped Dual Lumen IupKXO · Traditional | 08/15/1989SE |
| K881857 | Amnicath(Tm) Model Dt-Iupc Trans. Tipped Intrau.KXO · Traditional | 02/01/1989SE |
| K885235 | Safe-Draw(Tm) Blood Sampling Reservoir & Access.DSK · Traditional | 01/25/1989SE |
| K881825 | Models SP5825/SP5835/SP5845/SP5855 Percu. SheathDYB · Traditional | 09/28/1988SE |
| K875337 | Heparin Coated Luminal Pacing CatheterDQO · Traditional | 05/25/1988SE |
| K880740 | Model TA-CS10 Spectraject Control SyringeDQF · Traditional | 03/22/1988SE |
| K873168 | Spectramed Disposable Transducer (Dt-Xxo) & AccessDRS · Traditional | 01/12/1988SE |
| K871573 | Central Venous Multi-Lumen Catheters and KitsDQY · Traditional | 09/16/1987SE |
Questions and answers
When was Amnicathdl(Tm) DT-IUPC2 Dual Lumen Trans. Tipped cleared by the FDA?
Amnicathdl(Tm) DT-IUPC2 Dual Lumen Trans. Tipped (K896122) received a 510(k) decision of Substantially Equivalent on January 19, 1990, 87 days after the submission was received.
What is the product code of K896122?
The FDA product code is KXO – Monitor, Pressure, Intrauterine, a Class II (moderate risk) device regulated under 21 CFR 884.2700.