IS-1 HEMOSTASIS VALVE, MODEL 6799
FDA 510(k) clearance K031398 · decided 2003-05-20
Clearance details
- K-number
- K031398
- Device name
- IS-1 HEMOSTASIS VALVE, MODEL 6799
- Applicant
- Guidant Corp.
- Decision
- Substantially Equivalent
- Date received
- 2003-05-05
- Decision date
- 2003-05-20
- Days to decision
- 15 days
- Clearance type
- Special
- Product code
- DTL
- Device class
- 2
- Regulation number
- 870.4290
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- St Paul, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.