INTESTOPLANT
FDA 510(k) clearance K862412 · decided 1986-11-13
Clearance details
- K-number
- K862412
- Device name
- INTESTOPLANT
- Applicant
- Burron Medical Products, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-06-25
- Decision date
- 1986-11-13
- Days to decision
- 141 days
- Clearance type
- Traditional
- Product code
- LLD
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PORT-A-CATH IMPLANTABLE DRUG DELIVERY SYSTEM (K880072) | Pharmacia Deltec, Inc. | 1988-03-29 |
| PORT-A-CATH IMPLANTABLE CATHETER SYSTEM (K864552) | Pharmacia, Inc. | 1987-03-31 |
| PORT-A-CATH IMPLANTABLE CATHETER SYS (K832906) | Pharmacia, Inc. | 1984-03-06 |
Recalls involving this device
No recalls on record reference this clearance.