VYGON SPLIT CANNULA INTRODUCER
FDA 510(k) clearance K010913 · decided 2001-09-28
Clearance details
- K-number
- K010913
- Device name
- VYGON SPLIT CANNULA INTRODUCER
- Applicant
- Vygon Corp.
- Decision
- Substantially Equivalent
- Date received
- 2001-03-27
- Decision date
- 2001-09-28
- Days to decision
- 185 days
- Clearance type
- Traditional
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- West Cadwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.