Millar Mikro-Tip Catheter Pressure Transducer
FDA 510(k) K883651 · Millar Instruments, Inc.
510(k) numberK883651
Submission
- Device name
- Millar Mikro-Tip Catheter Pressure Transducer
- Applicant
- Millar Instruments, Inc.
Houston, TX, US - Received
- August 26, 1988
- Decision date
- November 18, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
Other 510(k)s with product code DQO
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|---|---|---|---|
| K261455 | Arterial Pressure Monitoring Set/TrayDQO · Traditional | Spectrum Vascular | 06/26/2026SE |
| K252702 | Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF…DQO · Traditional | Bioptimal International Pte. , Ltd. | 05/28/2026SE |
| K254278 | Arterial Pressure Monitoring Set/TrayDQO · Special | Spectrum Vascular | 03/25/2026SE |
| K250751 | DualView CatheterDQO · Traditional | Terumo Corporation | 07/17/2025SE |
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | Gentuity, LLC | 01/31/2025SE |
| K242420 | pNOVUS 21 MicrocatheterDQO · Traditional | Phenox, Ltd. | 11/12/2024SE |
| K233268 | Impress Angiographic CatheterDQO · Special | Merit Medical Systems, Inc. | 05/22/2024SE |
| K233975 | Zoom 6F Insert CathetersDQO · Traditional | Imperative Care, Inc. | 04/02/2024SE |
| K232536 | Soldier MicrocatheterDQO · Traditional | Embolx, Inc. | 02/23/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | Cordis US Corp | 11/21/2023SE |
More from Cordis US Corp
| 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 |
| K860766 | Millar Pulsed Doppler VelocimeterDPW · Traditional | 07/29/1986SE |
Questions and answers
When was Millar Mikro-Tip Catheter Pressure Transducer cleared by the FDA?
Millar Mikro-Tip Catheter Pressure Transducer (K883651) received a 510(k) decision of Substantially Equivalent on November 18, 1988, 84 days after the submission was received.
What is the product code of K883651?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.