PERIVAC KIT
FDA 510(k) clearance K032050 · decided 2003-08-08
Clearance details
- K-number
- K032050
- Device name
- PERIVAC KIT
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2003-07-02
- Decision date
- 2003-08-08
- Days to decision
- 37 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| PeriVac brand Pericardial Fluid Aspiration Procedure Kit (Pericardiocentensis Kit), with P recall (Z-0071-04) | Boston Scientific | 2003-10-30 |