Millar Mikro-Tip Catheter Phonotrans
FDA 510(k) K802830 · Millar Instruments, Inc.
510(k) numberK802830
Submission
- Device name
- Millar Mikro-Tip Catheter Phonotrans
- Applicant
- Millar Instruments, Inc.
Mchenry, IL, US - Received
- November 10, 1980
- Decision date
- December 10, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DXW – System, Phonocatheter, Intracavitary
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1270
- Specialty
- Cardiovascular
Other 510(k)s with product code DXW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972020 | Oscillomate Non-Invasive Blood Pressure MonitorDXW · Traditional | Cas Medical Systems, Inc. | 05/05/1998SE |
| K955887 | Newmed Abp-LiteDXW · Traditional | Newmed Corp. | 09/05/1996SE |
| K800222 | Model 412 Electrofluidic ManometerDXW · Traditional | Med-Tek Corp. | 02/29/1980SE |
| K800179 | Infrasonde Auto/Inflator Elec. VibratorDXW · Traditional | Sphygmetrics, Inc. | 02/11/1980SE |
More from Sphygmetrics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K112323 | Cardia-CathDXO · Special | 10/18/2011SE |
| K093111 | Mikro-Cath, Model 825-0101DXO · Abbreviated | 01/05/2010SE |
| K013205 | Millar Pressure Control Unit Model PCU-2000DRQ · Traditional | 07/02/2002SE |
| K993694 | Mikro-Tip Angiographic CatheterDQO · Special | 03/01/2000SE |
| K952773 | Mikro-Tip Angiographic CatheterDQO · Traditional | 11/07/1995SE |
| K935166 | Flow Directed Mikro-Tip Pressure TransducerDXO · Traditional | 08/05/1994SE |
| K915775 | Millar Nonmagnectic Mikro-Tip Catheter Press. TranDXO · Traditional | 04/20/1992SE |
| K896264 | Millar Mikro-Tip Doppler CatheterJOP · Traditional | 01/24/1990SE |
| K895721 | Millar Mikro-Tip Pulse TransducerDXO · Traditional | 12/07/1989SE |
| K883651 | Millar Mikro-Tip Catheter Pressure TransducerDQO · Traditional | 11/18/1988SE |
Questions and answers
When was Millar Mikro-Tip Catheter Phonotrans cleared by the FDA?
Millar Mikro-Tip Catheter Phonotrans (K802830) received a 510(k) decision of Substantially Equivalent on December 10, 1980, 30 days after the submission was received.
What is the product code of K802830?
The FDA product code is DXW – System, Phonocatheter, Intracavitary, a Class II (moderate risk) device regulated under 21 CFR 870.1270.