Port-A-Cath Implantable Catheter System
FDA 510(k) K864552 · Pharmacia, Inc.
510(k) numberK864552
Submission
- Device name
- Port-A-Cath Implantable Catheter System
- Applicant
- Pharmacia, Inc.
Piscataway, NJ, US - Received
- November 19, 1986
- Decision date
- March 31, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LLD – Port & Catheter, Implanted, Subcutaneous, Intraperitoneal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5965
- Specialty
- General Hospital
- Implant
- Yes
Other 510(k)s with product code LLD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880072 | Port-A-Cath Implantable Drug Delivery SystemLLD · Traditional | Pharmacia Deltec, Inc. | 03/29/1988SE |
| K862412 | IntestoplantLLD · Traditional | Burron Medical Products, Inc. | 11/13/1986SE |
| K832906 | Port-A-Cath Implantable Catheter SysLLD · Traditional | Pharmacia, Inc. | 03/06/1984SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K974350 | Allergan Immuno Cap M4, M8, K70DHB · Traditional | 02/09/1998SE |
| K972364 | Unicap PhadiatopDHB · Traditional | 09/04/1997SE |
| K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82DHB · Traditional | 07/03/1997SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | 06/30/1997SE |
| K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHDGC · Traditional | 04/23/1997SE |
| K962274 | Unicap 100DHB · Traditional | 09/12/1996SE |
| K941993 | Pharmacia Cap System Phadiatop FeiaDHB · Traditional | 01/30/1996SE |
| K954337 | Genotropin MixerFMF · Traditional | 11/13/1995SE |
| K951025 | Piston SyringeFMF · Traditional | 10/19/1995SE |
| K952025 | RobocapJQW · Traditional | 07/26/1995SE |
Questions and answers
When was Port-A-Cath Implantable Catheter System cleared by the FDA?
Port-A-Cath Implantable Catheter System (K864552) received a 510(k) decision of Substantially Equivalent on March 31, 1987, 132 days after the submission was received.
What is the product code of K864552?
The FDA product code is LLD – Port & Catheter, Implanted, Subcutaneous, Intraperitoneal, a Class II (moderate risk) device regulated under 21 CFR 880.5965.