Mikro-Tip Cath. Pressure Transducer
FDA 510(k) K830909 · Millar Instruments, Inc.
510(k) numberK830909
Submission
- Device name
- Mikro-Tip Cath. Pressure Transducer
- Applicant
- Millar Instruments, Inc.
Walker, MI, US - Received
- March 21, 1983
- Decision date
- April 18, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRB – Probe, Thermodilution
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1915
- Specialty
- Cardiovascular
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| K902627 | Interflo Medical Model Oxi/Co Fila. Thermo. Cath.KRB · Traditional | Biometric Research Institute, Inc. | 02/25/1991SE |
| K900710 | Interflo Medical Model F-1 Thermodilution CatheterKRB · Traditional | Intec Medical, Inc. | 10/19/1990SE |
More from Intec Medical, 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 Mikro-Tip Cath. Pressure Transducer cleared by the FDA?
Mikro-Tip Cath. Pressure Transducer (K830909) received a 510(k) decision of Substantially Equivalent on April 18, 1983, 28 days after the submission was received.
What is the product code of K830909?
The FDA product code is KRB – Probe, Thermodilution, a Class II (moderate risk) device regulated under 21 CFR 870.1915.