ARROW ECHOGENIC INTRODUCER NEEDLE
FDA 510(k) clearance K040100 · decided 2004-03-01
Clearance details
- K-number
- K040100
- Device name
- ARROW ECHOGENIC INTRODUCER NEEDLE
- Applicant
- Arrow Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 2004-01-20
- Decision date
- 2004-03-01
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Reading, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.