IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
FDA 510(k) clearance K002770 · decided 2000-09-26
Clearance details
- K-number
- K002770
- Device name
- IBIS CHEMO-PORT IMPLANTABLE VASCULAR ACCESS SYSTEM, MODEL 700-08-10,700-08-11,700-08-12,700-08-15,700-08-16,735-08-10
- Applicant
- Hdc Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-09-06
- Decision date
- 2000-09-26
- Days to decision
- 20 days
- Clearance type
- Special
- Product code
- LJT
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- San Jose, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.