Millar Pulsed Doppler Velocimeter
FDA 510(k) K860766 · Millar Instruments, Inc.
510(k) numberK860766
Submission
- Device name
- Millar Pulsed Doppler Velocimeter
- Applicant
- Millar Instruments, Inc.
Houston, TX, US - Received
- March 3, 1986
- Decision date
- July 29, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
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| 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 Pulsed Doppler Velocimeter cleared by the FDA?
Millar Pulsed Doppler Velocimeter (K860766) received a 510(k) decision of Substantially Equivalent on July 29, 1986, 148 days after the submission was received.
What is the product code of K860766?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.