Millar Mikro-Tip Catheter Pressure Tran.
FDA 510(k) K812944 · Millar Instruments, Inc.
510(k) numberK812944
Submission
- Device name
- Millar Mikro-Tip Catheter Pressure Tran.
- Applicant
- Millar Instruments, Inc.
Mchenry, IL, US - Received
- October 20, 1981
- Decision date
- November 16, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
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|---|---|---|---|
| K252794 | Vision-MR Diagnostic CatheterDRF · Traditional | Imricor Medical Systems, Inc. | 01/08/2026SE |
| K250590 | MAGiC Sweep EP Mapping CatheterDRF · Traditional | Stereotaxis, Inc. | 07/23/2025SE |
| K250310 | VIKING Fixed Curve Diagnostic CatheterDRF · Traditional | Boston Scientific Corporation | 06/27/2025SE |
| K240366 | EPXT Unidirectional Steerable Diagnostic Catheter; Dynamic Tip Unidirectional…DRF · Traditional | Boston Scientific Corporation | 11/01/2024SE |
| K233900 | Nordica PV Cryo Mapping CatheterDRF · Traditional | Synaptic Medical Corporation | 09/06/2024SE |
| K233397 | Cosine-10TM Diagnostic CatheterDRF · Traditional | Medtronic, Inc. | 12/02/2023SE |
| K233207 | Polaris X Unidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 10/27/2023SE |
| K232651 | BLAZER Dx-20 Bidirectional Steerable Diagnostic CatheterDRF · Special | Boston Scientific Corporation | 09/29/2023SE |
| K230503 | Polaris X Catheter Cable, Blazer Dx-20 Catheter CableDRF · Traditional | Boston Scientific | 04/25/2023SE |
| K210313 | EasyFinder Fixed Curve Diagnostic Catheter, Forlnk Cable for Mapping CatheterDRF · Traditional | Shanghai Microport EP Medtech Co., Ltd. | 12/30/2022SE |
More from Shanghai Microport EP Medtech Co., Ltd.
| 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 Pressure Tran. cleared by the FDA?
Millar Mikro-Tip Catheter Pressure Tran. (K812944) received a 510(k) decision of Substantially Equivalent on November 16, 1981, 27 days after the submission was received.
What is the product code of K812944?
The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.