VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
FDA 510(k) clearance K982888 · decided 1998-10-20
Clearance details
- K-number
- K982888
- Device name
- VAXCEL IMPANTABLE VASCULAR ACCESS SYSTEM
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1998-08-17
- Decision date
- 1998-10-20
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.