DAIG VESSEL DILATOR
FDA 510(k) clearance K894330 · decided 1989-09-12
Clearance details
- K-number
- K894330
- Device name
- DAIG VESSEL DILATOR
- Applicant
- Daig Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-07-14
- Decision date
- 1989-09-12
- Days to decision
- 60 days
- Clearance type
- Traditional
- Product code
- DRE
- Device class
- 2
- Regulation number
- 870.1310
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Minnetonka, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.