PORT-A-CATH IMPLANTABLE CATHETER SYS
FDA 510(k) clearance K832906 · decided 1984-03-06
Clearance details
- K-number
- K832906
- Device name
- PORT-A-CATH IMPLANTABLE CATHETER SYS
- Applicant
- Pharmacia, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-29
- Decision date
- 1984-03-06
- Days to decision
- 190 days
- Clearance type
- Traditional
- Product code
- LLD
- Device class
- 2
- Regulation number
- 880.5965
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Mchenry, IL, 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 |
| INTESTOPLANT (K862412) | Burron Medical Products, Inc. | 1986-11-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| MODELS 011 & 011B IRIDOCAPSULAR IOLS (P810042) | Pharmacia, Inc. | 1982-12-15 |