SINGLE WALL INTRODUCER NEEDLE
FDA 510(k) clearance K843719 · decided 1984-10-18
Clearance details
- K-number
- K843719
- Device name
- SINGLE WALL INTRODUCER NEEDLE
- Applicant
- Ocean Medical Products, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1984-09-24
- Decision date
- 1984-10-18
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Wyoming, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.