VASCULAR ASSIST
FDA 510(k) clearance K002186 · decided 2001-05-02
Clearance details
- K-number
- K002186
- Device name
- VASCULAR ASSIST
- Applicant
- Huntleigh Healthcare, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-20
- Decision date
- 2001-05-02
- Days to decision
- 286 days
- Clearance type
- Traditional
- Product code
- DPW
- Device class
- 2
- Regulation number
- 870.2100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Eatontown, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18 recall (Z-0865-05) | Philips Ultrasound, Inc. | 2005-06-03 |