MIKRO-TIP ANGIOGRAPHIC CATHETER
FDA 510(k) clearance K993694 · decided 2000-03-01
Clearance details
- K-number
- K993694
- Device name
- MIKRO-TIP ANGIOGRAPHIC CATHETER
- Applicant
- Millar Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-11-02
- Decision date
- 2000-03-01
- Days to decision
- 120 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Millar Instruments, Inc. Millar Sensors Systems Solutions Mikro-Tip Angiographic Catheters recall (Z-1725-2011) | Millar Instruments, Inc | 2011-03-24 |
| Millar Disposable Angiographic Catheter (Left Heart), manufactured for Millar Instruments, recall (Z-0401-2011) | Millar Instruments, Inc | 2010-11-17 |
| Mikro-Tip Disposable Angiographic Catheter manufactured by Millar Instruments, Houston, Te recall (Z-0635-05) | Millar Instruments, Inc | 2005-03-18 |