DOLPHIN INFLATION DEVICE
FDA 510(k) clearance K042449 · decided 2005-04-18
Clearance details
- K-number
- K042449
- Device name
- DOLPHIN INFLATION DEVICE
- Applicant
- Sedat S.A.
- Decision
- Substantially Equivalent
- Date received
- 2004-09-09
- Decision date
- 2005-04-18
- Days to decision
- 221 days
- Clearance type
- Traditional
- Product code
- MAV
- Device class
- 2
- Regulation number
- 870.1650
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Temecula, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Bard Caliber (CL3030) Inflation Device Product Usage: Inflation Device intended for use du recall (Z-0876-2015) | PEROUSE MEDICAL | 2014-12-29 |