Port-A-Cath Implantable Drug Delivery System

Q: What is the product code of K880072?

The FDA product code is LLD – Port & Catheter, Implanted, Subcutaneous, Intraperitoneal, a Class II (moderate risk) device regulated under 21 CFR 880.5965.

FDA 510(k) K880072 · Pharmacia Deltec, Inc.

Substantially Equivalent

510(k) numberK880072

Submission

Device name: Port-A-Cath Implantable Drug Delivery System
Applicant: Pharmacia Deltec, Inc.
St. Paul, MN, US
Received: January 11, 1988
Decision date: March 29, 1988
Decision: Substantially Equivalent (SESE)
Type: Traditional 510(k)

Official FDA 510(k) record

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
K864552	Port-A-Cath Implantable Catheter SystemLLD · Traditional	Pharmacia, Inc.	03/31/1987SE
K862412	IntestoplantLLD · Traditional	Burron Medical Products, Inc.	11/13/1986SE
K832906	Port-A-Cath Implantable Catheter SysLLD · Traditional	Pharmacia, Inc.	03/06/1984SE

More from Pharmacia, Inc.

510(k)	Device	Decision
K943310	Model 6100 Ambulatory Infusion SystemMEA · Traditional	02/21/1995ST
K942046	Pharmacia Deltec Extension Set with Anti-Siphon ValveFPA · Traditional	10/04/1994SE
K942161	LockboxFRN · Traditional	08/02/1994ST
K942024	Port-A-Cath Low Profile Implantable Venous Access SystemLJT · Traditional	07/26/1994SE
K941445	Extension Set with Anti-Siphon ValveFPA · Traditional	06/29/1994SE
K931073	Cath-FinderFOZ · Traditional	05/05/1994SE
K932464	Peripherallyinsrted Venous Cath. Alternate Cath.LJS · Traditional	05/02/1994SESK
K932433	Pheripherally Inserted Venous Catheter-Y SiteLJS · Traditional	05/02/1994SESK
K932430	Dual Lumen Peripherally Inserted Venous CatheterLJS · Traditional	05/02/1994SESK
K932211	Procedural Tray for Peripherally Inserted VenousLJS · Traditional	05/02/1994SE

Questions and answers

When was Port-A-Cath Implantable Drug Delivery System cleared by the FDA?

Port-A-Cath Implantable Drug Delivery System (K880072) received a 510(k) decision of Substantially Equivalent on March 29, 1988, 78 days after the submission was received.

What is the product code of K880072?

The FDA product code is LLD – Port & Catheter, Implanted, Subcutaneous, Intraperitoneal, a Class II (moderate risk) device regulated under 21 CFR 880.5965.