Mikro-Tip Angiographic Catheter
FDA 510(k) K993694 · Millar Instruments, Inc.
510(k) numberK993694
Submission
- Device name
- Mikro-Tip Angiographic Catheter
- Applicant
- Millar Instruments, Inc.
Houston, TX, US - Received
- November 2, 1999
- Decision date
- March 1, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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| 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 |
| 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 |
| K860766 | Millar Pulsed Doppler VelocimeterDPW · Traditional | 07/29/1986SE |
Questions and answers
When was Mikro-Tip Angiographic Catheter cleared by the FDA?
Mikro-Tip Angiographic Catheter (K993694) received a 510(k) decision of Substantially Equivalent on March 1, 2000, 120 days after the submission was received.
What is the product code of K993694?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.