ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975
FDA 510(k) clearance K040776 · decided 2004-04-29
Clearance details
- K-number
- K040776
- Device name
- ATLANTIS SR, MODEL C4020; ATLANTIS SR PLUS, MODEL 35975
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2004-03-26
- Decision date
- 2004-04-29
- Days to decision
- 34 days
- Clearance type
- Special
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Fremont, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.