PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
FDA 510(k) clearance K040867 · decided 2004-04-30
Clearance details
- K-number
- K040867
- Device name
- PERIVAC KIT, MODELS 4304, 4305, 4314, 4315
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-04-02
- Decision date
- 2004-04-30
- Days to decision
- 28 days
- Clearance type
- Special
- 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
No recalls on record reference this clearance.